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U.S. Department of Health and Human Services

Class 2 Device Recall Nimbus 4 and Nimbus Professional

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 Class 2 Device Recall Nimbus 4 and Nimbus Professionalsee related information
Date Initiated by FirmApril 15, 2021
Create DateJune 04, 2021
Recall Status1 Terminated 3 on November 13, 2023
Recall NumberZ-1788-2021
Recall Event ID 87752
Product Classification Mattress, air flotation, alternating pressure - Product Code FNM
ProductNimbus 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)
FEI Number 3005619970
Recalling Firm/
Manufacturer		 Getinge (Suzhou) Co Ltd
NO 158 Fangzhoulu
Zhong Xin Gongyeyuanqu
Suzhou City China
Manufacturer Reason
for Recall		There is a potential for abnormal inflation of the mattress.
FDA Determined
Cause 2		Under Investigation by firm
ActionCustomers 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 Commerce13042 units
DistributionUSA
Total Product Life CycleTPLC Device Report
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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