Exact FDA event identifier

Event 83655

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: August 15, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Siemens Healthcare Diagnostics, 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

2 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 2

Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001

Z-0204-2020

Recall number: Z-0204-2020
Initiated: August 15, 2019
Classification: Class II
Status: Terminated
Recalling firm: Siemens Healthcare Diagnostics, Inc.
Quantity: 88 total US: 54;OUS 34

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

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

Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

Code information

(SW) version V1.19.0 and V1.19.2 UDI: 00630414007960

Distribution pattern

Nationwide Foreign: Argentina Australia Bangladesh Belgium Brazil Colombia Dominican Republic Finland France Germany Greece Italy Japan Latvia Mexico Netherlands P.R. China Republic Korea Singapore Spain Switzerland Thailand United Kingdom Vietnam

device · product 2 of 2

Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000

Z-0205-2020

Recall number: Z-0205-2020
Initiated: August 15, 2019
Classification: Class II
Status: Terminated
Recalling firm: Siemens Healthcare Diagnostics, Inc.
Quantity: 166 total US: 15; OUS:151

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

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

Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

Code information

(SW) version V1.19.0 and V1.19.2 UDI: 00630414002026