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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71777

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

Open FDA event record

Event summary

Timeline bucket
June 26, 2015
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Getinge Disinfection Ab

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 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

Z-2419-2015
Recall number
Z-2419-2015
Initiated
June 26, 2015
Classification
Class III
Status
Terminated
Recalling firm
Getinge Disinfection Ab
Quantity
20 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network.

Code information

Software versions up to and including 1.5.1.

Distribution pattern

Distributed in CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, and WA.