Nimbus alternating-pressure mattress overlay system recall for inflation malfunction
Getinge is recalling approximately 13,042 units of Nimbus 4 and Nimbus Professional alternating-pressure mattress overlays due to potential abnormal inflation that could impair pressure relief function.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device where the potential for abnormal inflation could compromise the mattress overlay's pressure relief function. No reported illnesses or injuries are mentioned in the recall notice, so per the rubric, the score does not exceed 3.
Plain-English summary
Getinge (Suzhou) Co Ltd is recalling approximately 13,042 units of the Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay systems distributed in the United States. The recalled systems are identified by the following model numbers: 650001ADV, 650001DAR, 650001P, 650201DAR, 651001, 651001ADV, 651001DAR, 651001DARW, 651001P, 651201DAR, and 651201P (Product Code: 47478).
The alternating-pressure mattress overlay systems have a potential for abnormal inflation. This malfunction could impair the device's ability to function as intended and maintain proper alternating pressure support for the user.
Individuals who possess affected units should contact Getinge (Suzhou) Co Ltd for further information. The manufacturer can provide guidance on inspection, repair, or replacement of the recalled device.
The recalled product
- Product
- Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
- Manufacturer
- Getinge (Suzhou) Co Ltd
- Affected units
- 13,042
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Model Numbers: 650001ADV
- 650001DAR
- 650001P
- 650201DAR
- 651001
- 651001ADV
- 651001DAR
- 651001DARW
- 651001P
- 651201DAR
- 651201P Product Code: 47478 (GMDN nomenclature code)
Distribution
Distribution scope not specified by the agency.
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