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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75210

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

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Event summary

Timeline bucket
August 04, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GE Healthcare, LLC

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

Infant Warmer System (IWS)

Z-1015-2017
Recall number
Z-1015-2017
Initiated
August 04, 2016
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
32,073 (US = 24,361; OUS = 7,712)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall onto the bed if the Heater Head assembly has been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient could result. Two injuries have been reported as a result of this issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

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Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall onto the bed if the Heater Head assembly has been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient could result. Two injuries have been reported as a result of this issue.

Code information

Medical device listing number: D103053, D103054, D103056, D103057, D183529

Distribution pattern

This product has been distributed domestically and internationally .