Del Mar Reynolds Medical recalls
Del Mar Reynolds Medical appears in 8 official U.S. recall notices indexed by RecallRadar, most recently on 2017-05-24.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 8 |
|---|---|
| Published | 2012-12-26 to 2017-05-24 |
| By agency | FDA Device (8) |
| By classification | Class II (5), Class I (3) |
| By status | terminated (8) |
| Distribution named in notices | FL, LA, MS, NC, SC, US, WA, WY |
Recalls
- Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room
FDA Device · Class II · 2017-05-24 · Del Mar Reynolds Medical
Reason: Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation in the patient. - Arkon Anesthesia Delivery System, Model 99999
FDA Device · Class II · 2017-03-22 · Del Mar Reynolds Medical
Reason: Spacelabs has received reports of the Arkon Anesthesia Delivery System, Model 99999, shutting down without warning. The power supply has failed in a way that does not trigger the normal on battery alarms. - Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00
FDA Device · Class II · 2015-04-29 · Del Mar Reynolds Medical
Reason: Reports of inaccurate low flow readings. Monitored inspiratory tidal volume (VTi) and expiratory tidal volume (Vte) measurements from the pediatric flow sensor are reporting out of specification low compared to the actu… - SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed
FDA Device · Class I · 2014-04-23 · Del Mar Reynolds Medical
Reason: The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence. - CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following par…
FDA Device · Class I · 2013-11-27 · Del Mar Reynolds Medical
Reason: Spacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in CAS I/II Absorbers may fail due to loose fastening hardware in an absorber. - Spacelabs ARKON Anesthesia Workstation
FDA Device · Class II · 2013-07-31 · Del Mar Reynolds Medical
Reason: Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs, a buzzer will activate and a… - Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Num…
FDA Device · Class I · 2013-03-27 · Del Mar Reynolds Medical
Reason: A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the pa… - BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine
FDA Device · Class II · 2012-12-26 · Del Mar Reynolds Medical
Reason: The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals that describe a secondary O2 Supply Failure alarm which has not been incorporated into the system. The manuals were prematu…