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Class 1 Device Recall Giraffe OmniBed |
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Date Initiated by Firm |
October 11, 2019 |
Date Posted |
December 03, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0538-2020 |
Recall Event ID |
84077 |
510(K)Number |
K020543 K101788
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Product Classification |
Warmer, infant radiant - Product Code FMT
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Product |
Giraffe OmniBed infant warmer |
Code Information |
Model Numbers:
6650-0XXX-XXX
2074920-00X-XXXXXX
M1050205
M1136116
M1136215
M1139253
M1145528
M1145529
M1146094
M1149051
M1149079
M1149081
M1149087
M1149108
M1161324
M1161328
M1161338
M1162796
M1206147
M1235957
Updated 6/3/2021 - All model numbers and units are affected.
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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 |
23,693 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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510(K) Database |
510(K)s with Product Code = FMT and Original Applicant = OHMEDA MEDICAL
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