FDA Device recall Z-2156-2021
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
- terminated
- Published 2021-08-04
On 2021-08-04 the FDA classified a Class II recall of 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… by Hill Rom, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2156-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-28 |
| Published | 2021-08-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Hill Rom |
| Distribution | US |
Product
Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market Model Numbers: P3700B, P3700C, P3700D, & P3700E
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 due to a fall.
Identifiers
| code_info | Serial Numbers: US Serial Numbers: P328AA3855 P314AA3735 P311AA3734 P311AA3733 P304AA3675 I067AA5445 O351AA1238 J130AA…Serial Numbers: US Serial Numbers: P328AA3855 P314AA3735 P311AA3734 P311AA3733 P304AA3675 I067AA5445 O351AA1238 J130AA8820 K226AA1383 I135AA6134 O161AA3 P314AA3737 P343AA3930 P343AA3929 P343AA3920 P343AA3919 P343AA3918 P314AA3736 P323AA3813 P323AA3812 P322AA3811 P322AA3810 P322AA3809 P322AA3808 I004AA4998 I156AA6325 P295AA3605 I267AA7216 J155AA8988 J161AA9040 J168AA9110 J168AA9099 J162AA9047 J154AA8977 P346AA3966. OUS: Serial Numbers: I299AA7436 O004AA0116 M117AA5556 M115AA5531 M115AA5527 P286AA3531 N124AA8303 M055AA5218 M053AA5199 P106AA2178 M160AA5829 M166AA5877 M053AA5198 M172AA5924 M180AA5992 M180AA5990 P288AA3551 M054AA5210 M054AA5202 P274AA3445 N199AA8761 M054AA5205 N083AA7986 M166AA5872 N121AA8271 P275AA3452 P283AA3524 P274AA3441 N017AA7471 P288AA3552 N272AA9378 N017AA7473 M049AA5176 P281AA3497 P279AA3471 N018AA7480 P280AA3486 N089AA8038 M166AA5880 M075AA5294 N090AA8040 N083AA7988 O197AA0505 O196AA0502 O108AA0048 N074AA7913 N124AA8304 M053AA5193 M052AA5182 P280AA3490 P077AA19 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2156-2021%22
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