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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87752

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 15, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Getinge (Suzhou) Co Ltd

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1788-2021
Recall number
Z-1788-2021
Initiated
April 15, 2021
Classification
Class II
Status
Terminated
Recalling firm
Getinge (Suzhou) Co Ltd
Quantity
13042 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for abnormal inflation of the mattress.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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