Recall Z-2323-2017— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2017-05-05, terminated 2018-07-12. It names 5 FDA 510(k) clearances: K963058, K921766, K884160 and 2 more. Product: Infant Warmer System (IWS). Reason: GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall onto the bed if the Heater Head assembly has been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient could result. Two injuries have been reported as a result of this issue..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-05
- Terminated
- 2018-07-12
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
5 on FDA's record- K963058 — INFANT WARMER SYSTEM
- K921766 — OHIO INFANT WARMER SYSTEM
- K884160 — OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM
- K851449 — OHMEDA 5000 INFANT WARMER SYSTEM
- K840858 — OHIO 3300 INFANT WARMER SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Infant Warmer System (IWS)
Reason for recall
GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall onto the bed if the Heater Head assembly has been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient could result. Two injuries have been reported as a result of this issue.
Data sourced from openFDA. This site is unofficial and independent of the FDA.