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Class 2 Device Recall Nimbus 4 and Nimbus Professional |
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Date Initiated by Firm |
April 15, 2021 |
Create Date |
June 04, 2021 |
Recall Status1 |
Terminated 3 on November 13, 2023 |
Recall Number |
Z-1788-2021 |
Recall Event ID |
87752 |
Product Classification |
Mattress, air flotation, alternating pressure - Product Code FNM
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Product |
Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system |
Code Information |
Model Numbers: 650001ADV, 650001DAR, 650001P, 650201DAR, 651001, 651001ADV, 651001DAR, 651001DARW, 651001P, 651201DAR, 651201P Product Code: 47478 (GMDN nomenclature code) |
Recalling Firm/ Manufacturer |
Getinge (Suzhou) Co Ltd NO 158 Fangzhoulu Zhong Xin Gongyeyuanqu Suzhou City China
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Manufacturer Reason for Recall |
There is a potential for abnormal inflation of the mattress.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Customers identified as owners of the affected mattresses will be notified of the identified product risk and the Field Safety Corrective Action through the Field Safety Notice.
The Field Safety Notice will be accompanied by Customer Response Form.
The Field Safety Notice will be accompanied by a video recording. The video demonstrates how to remove the over-inflation risk immediately through puncture of two grommet membranes in the mattress that can be performed on-site.
Throughout technical evaluation has confirmed that the puncture of grommet membranes eliminates the patient fall risk and does not introduce any new harm.
The customer will be asked to acknowledge the FSN, complete and sign an enclosed Customer Response Form and return it to the local Arjo office (address indicated in the FSN) in order to confirm that the advised activity has been completed following the provided instruction. |
Quantity in Commerce |
13042 units |
Distribution |
USA |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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