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Recall Observatory FDA recall evidence

Device product

Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system

Z-1788-2021

April 15, 2021

Class II

Product summary

Firm
Getinge (Suzhou) Co Ltd
Event
Event 87752
Status
Terminated
Classification
Class II
Quantity
13042 units
Official record key
device-enforcement:Z-1788-2021

Official wording

Reason: There is a potential for abnormal inflation of the mattress.

Code information: Model Numbers: 650001ADV, 650001DAR, 650001P, 650201DAR, 651001, 651001ADV, 651001DAR, 651001DARW, 651001P, 651201DAR, 651201P Product Code: 47478 (GMDN nomenclature code)

Distribution pattern: USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for abnormal inflation of the mattress.