Getinge (Suzhou) Co Ltd NO 158 Fangzhoulu Zhong Xin Gongyeyuanqu Suzhou City China Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
Brand
Getinge (Suzhou) Co Ltd NO 158 Fangzhoulu Zhong Xin Gongyeyuanqu Suzhou City China
Lot Codes / Batch Numbers
Model Numbers: 650001ADV, 650001DAR, 650001P, 650201DAR, 651001, 651001ADV, 651001DAR, 651001DARW, 651001P, 651201DAR, 651201P Product Code: 47478 (GMDN nomenclature code)
Products Sold
Model Numbers: 650001ADV, 650001DAR, 650001P, 650201DAR, 651001, 651001ADV, 651001DAR, 651001DARW, 651001P, 651201DAR, 651201P Product Code: 47478 (GMDN nomenclature code)
Getinge (Suzhou) Co Ltd NO 158 Fangzhoulu Zhong Xin Gongyeyuanqu Suzhou City China is recalling Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system due to There is a potential for abnormal inflation of the mattress.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for abnormal inflation of the mattress.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026