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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61974

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

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Event summary

Timeline bucket
May 25, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Getinge USA Inc

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

Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model numbers Getinge 9120, 9122, 9125, and 9128

Z-2079-2012
Recall number
Z-2079-2012
Initiated
May 25, 2012
Classification
Class II
Status
Terminated
Recalling firm
Getinge USA Inc
Quantity
8 washers

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
production error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heated 9100-Series manufactured between 2009-05-04 through 09-26-2011. This action is based on a report from the ground fault breaker manufacturer of a production error.

Code information

Serial numbers: W50024258; W50024259; W50026573; W50025790; W50017381; W50020296; W50028138; W50020952

Distribution pattern

Worldwide Distribution - USA including Maryland, Indiana, New Mexico, Massachuesetts, Texas, Kansas and the country of Canada