Hill Rom recalls
Hill Rom appears in 37 official U.S. recall notices indexed by RecallRadar, most recently on 2022-03-23.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 37 |
|---|---|
| Published | 2012-07-04 to 2022-03-23 |
| By agency | FDA Device (37) |
| By classification | Class II (36), Class I (1) |
| By status | terminated (30), ongoing (7) |
| Distribution named in notices | AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, US, VA, VT, WA, WI, WV, WY |
Recalls
- (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhea…
FDA Device · Class II · 2022-03-23 · Hill Rom
Reason: Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate installation. There is potential that the screws are unable to secure the traverse rail appropriately and could loosen over… - Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015
FDA Device · Class II · 2022-02-23 · Hill Rom
Reason: Missing bushing on Liko M220 and M230 causing wear and potential for patient falling - Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010
FDA Device · Class II · 2022-02-23 · Hill Rom
Reason: Missing bushing on Liko M220 and M230 causing wear and potential for patient falling - These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Pro…
FDA Device · Class II · 2021-12-29 · Hill Rom
Reason: An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced. - LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user to easily adjust/control the center of gravity du…
FDA Device · Class II · 2021-10-06 · Hill Rom
Reason: Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall… - OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during…
FDA Device · Class II · 2021-10-06 · Hill Rom
Reason: Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall… - FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the center of gravity during…
FDA Device · Class II · 2021-10-06 · Hill Rom
Reason: Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall… - LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combinati…
FDA Device · Class II · 2021-10-06 · Hill Rom
Reason: Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall… - Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily adjust/control the center of gravity du…
FDA Device · Class II · 2021-10-06 · Hill Rom
Reason: Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall… - Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Deli…
FDA Device · Class II · 2021-08-04 · Hill Rom
Reason: Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentially cause the installed foot section to be improperly engaged onto the bed, could result in injury to the user… - Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use in healthcare, intensive care and rehabilit…
FDA Device · Class I · 2021-02-10 · Hill Rom
Reason: Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by user, leading to the Multirall lift becoming detached from the rail system, potentially resulting in the fall of both the lift moto… - Centrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associate…
FDA Device · Class II · 2020-08-05 · Hill Rom
Reason: Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury. - Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with…
FDA Device · Class II · 2020-08-05 · Hill Rom
Reason: Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury. - Centrella Smart+ Bed, Catalog Number P7900
FDA Device · Class II · 2020-06-10 · Hill Rom
Reason: The Bed Exit System may fail to send a remote alert through the nurse call system if a remote alert was previously sent and cancelled at the in-room nurse call wall unit. - NaviCare Patient Safety Software Versions 3.5.400-3.9.300
FDA Device · Class II · 2020-04-01 · Hill Rom
Reason: There is a software issue which may result in failure to monitor or control patient's bed exit mechanism. - Progressa Bed - AC-powered adjustable hospital bed
FDA Device · Class II · 2018-04-18 · Hill Rom
Reason: A component used within the braking system may break resulting in one or more brake pedals on the bed staying in brake or not being engaged which could result in unwanted bed movement and possible patient or user injury. - TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Number…
FDA Device · Class II · 2017-04-19 · Hill Rom
Reason: The bed exit alarm may not function properly if the alarm has been armed for a period longer than seventy-two (72) hours without the alarm being triggered by patient movement or removal of patient weight within that tim… - Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 25…
FDA Device · Class II · 2016-11-09 · Hill Rom
Reason: Ceiling Bracket 71 was shipped with a larger center hole. A potentially hazardous situation exists that if the Ceiling Bracket 71 with a larger center hole is used for a concrete ceiling Ultra System installation with t… - Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated car…
FDA Device · Class II · 2016-09-14 · Hill Rom - Volker 2080, 2082, S 280 and S 282 series beds with lateral release button
FDA Device · Class II · 2016-08-17 · Hill Rom
Reason: The current construction of the side rail latch may not be able to support the full patient weight and may give way allowing the side rail to abruptly lower and the patient to fall, potentially resulting in harm. To dat… - Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH, Universal SlingBar" 350 R2R, Universal SlingBar" 450, Univer…
FDA Device · Class II · 2016-06-15 · Hill Rom
Reason: The center bolt of the sling bar, which connects the bar to the patient lift, has failed during use. If the sling bar is not used as intended the bolt may be weakened. If the bolt is weakened there is a potential risk f… - Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aestheticall…
FDA Device · Class II · 2016-03-02 · Hill Rom
Reason: The recliners were shipped without the foot rest ottoman linkage side shields, which could result in consumer injury. - Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed
FDA Device · Class II · 2015-11-25 · Hill Rom
Reason: Hill-Rom is voluntarily recalling the Hill-Rom 100 Low Bed due to complaints of patient injury when exiting the beds set at the lowest position setting. - Steriseal-Cannula Ophthalmic
FDA Device · Class II · 2015-07-01 · Hill Rom
Reason: The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece. - Viking M, L, and XL Mobile Lifts
FDA Device · Class II · 2015-06-24 · Hill Rom
Reason: Complaints (including one reported death) allegedly of the lift arm drifting down suddenly. If the lift arm assembly is manually lifted, the actuator can become damaged and get stuck in the highest position. If a patien… - Affinity¿ Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds for women of child bearing age in an LDR (Labor…
FDA Device · Class II · 2014-09-10 · Hill Rom
Reason: The attachment latch mechanism can become bent depending on user handling. Latch mechanism bending could lead to improper engagement of the foot section and this could result in injury to the user due to a fall. - TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The TotalC…
FDA Device · Class II · 2013-07-31 · Hill Rom
Reason: When the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of the mattress flat to the bed frame, and the mattress foot section will extend away from the bed at an angle. A p… - SlingBar 360
FDA Device · Class II · 2013-06-12 · Hill Rom
Reason: Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of i… - SlingBar 350
FDA Device · Class II · 2013-06-12 · Hill Rom
Reason: Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of i… - SlingBar Standard
FDA Device · Class II · 2013-06-12 · Hill Rom
Reason: Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of i… - SlingBar Wide 670
FDA Device · Class II · 2013-06-12 · Hill Rom
Reason: Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of i… - Hill-Rom 1000 Bed, Product No. P1160
FDA Device · Class II · 2013-06-12 · Hill Rom
Reason: Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or force to the frame. - TotalCare SpO2RT2 bed
FDA Device · Class II · 2013-03-20 · Hill Rom
Reason: In certain situations a software problem with the TotalCare SpO2RT¿ 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to adequately support the patient. This may increase the likel… - Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall, Multirall and Masterlift Systems…
FDA Device · Class II · 2013-02-27 · Hill Rom
Reason: Liko/Hill-Rom to date has received two reports from facilities alleging that the overhead rail system has failed to the extent that the overhead rails have fallen down while in use in high humidity (swimming pool) areas… - Liko Standard Slingbar 450
FDA Device · Class II · 2013-01-09 · Hill Rom
Reason: Liko/Hill-Rom has received reports from facilities which indicate that serious injuries have been received related to the Standard Sling bar 450. There have been 6 complaints of injury related to the product over the pa… - Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is intended to be used as birthing beds for women of child…
FDA Device · Class II · 2012-08-01 · Hill Rom
Reason: During review of our last braking system via that field corrective action, the system still did not meet our expectations, which is to eliminate the hazards of patient falling. Bed movement immediately prior to, or duri… - Advanta 2 Bed
FDA Device · Class II · 2012-07-04 · Hill Rom
Reason: During an evaluation of Advanta 2 siderail samples returned from the field it was found that the screws used to attach the siderail were being stripped from the plastic cavity of the siderail.