FDA Device recall Z-0281-2020
Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode…
- FDA Device
- Class II
- ongoing
- Published 2019-11-13
On 2019-11-13 the FDA classified a Class II recall of Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode… by Ge Healthcare, citing fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0281-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-07-26 |
| Published | 2019-11-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo regulate based on their own physiology.
Reason
Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.
Identifiers
| code_info | Model Number: 2082844-001; Serial Number (UDI Number): TABY70690 (010084068211686221TABY7069011190610), TABY70692 (…Model Number: 2082844-001; Serial Number (UDI Number): TABY70690 (010084068211686221TABY7069011190610), TABY70692 (010084068211686221TABY7069211190611), TABY70708 (010084068211686221TABY7070811190612), TABY70719 (010084068211686221TABY7071911190613), TABY70709 (010084068211686221TABY7070911190612), TABY70724 (010084068211686221TABY7072411190614), TABY70722 (010084068211686221TABY7072211190614), TABY70718 (010084068211686221TABY7064211190603), TABY70717 (010084068211686221TABY7064411190603), TABY70712 (010084068211686221TABY7064511190603), TABY70678 (010084068211686221TABY7067811190607), TABY70725 (010084068211686221TABY7072511190615), TABY70672 (010084068211686221TABY7067211190607), TABY70686 (010084068211686221TABY7068611190610), TABY70688 (010084068211686221TABY7068811190610), TABY70697 (010084068211686221TABY7069711190611), TABY70726 (010084068211686221TABY7072611190616), TABY70729 (010084068211686221TABY7072911190616), TABY70645 (010084068211686221TABY7064711190604), TABY70647 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0281-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.