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Class 1 Device Recall Giraffe Incubator |
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Date Initiated by Firm |
October 11, 2019 |
Date Posted |
December 03, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0541-2020 |
Recall Event ID |
84077 |
Product Classification |
Warmer, infant radiant - Product Code FMT
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Product |
Giraffe Incubator infant warmer |
Code Information |
Model Numbers:
6651-XXXX-XXX
2074921-00X-XXXXXX
M1050206
M1050207
M1136120
M1136222
M1136226
M1138367
M1145526
M1145527
M1146091
M1146092
M1148634
M1161351
M1161353
M1161357
M1206149
M1235958
Updated 6/3/2021 - All model numbers and units are affected. |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact |
GE Healthcare Service 800-437-1171
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Manufacturer Reason for Recall |
Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.
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FDA Determined Cause 2 |
Use error |
Action |
The firm disseminated its notices by letter beginning on 10/11/2019. The notices identified the following safety issues:
- The bedside panels of Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation can be upright and look closed but not be latched.
- The portholes also can look closed when not latched.
- If a canopy cover is used, it can hold the bedside panel or porthole door closed without being latched.
The product may continue to be used following specific safety instructions outlined in the notice.
On 11/8/2020, the firm issued an "Amended - Urgent Medical Device Recall" letter that supplemented the previous notification to provide additional safety instructions and materials (poster regarding risk of patient fall, user manual addendum, and labeling, including safety labels).
Update 6/3/2021: In the event a new consignee was identified, GE Healthcare has sent the original letter. |
Quantity in Commerce |
19425 units |
Distribution |
worldwide |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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