FDA Device recall Z-1071-2014
GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System
- FDA Device
- Class I
- terminated
- Published 2014-03-05
On 2014-03-05 the FDA classified a Class I recall of GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System by Ge Healthcare, citing oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1071-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-10-01 |
| Published | 2014-03-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage: The Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.
Reason
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
Identifiers
| code_info | QABS50026, QABR50066, QABR50068, QABR50133, QABS50023, QABR50102, QABR50103, QABR50064, QABR50065, QABR50067, QABS50070…QABS50026, QABR50066, QABR50068, QABR50133, QABS50023, QABR50102, QABR50103, QABR50064, QABR50065, QABR50067, QABS50070, QABS50069, QABR50275, QABS50027, QABR50274 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1071-2014%22
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