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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91518

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

Open FDA event record

Event summary

Timeline bucket
January 16, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Siemens Medical Solutions 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

3 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 3

SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission

Z-1134-2023
Recall number
Z-1134-2023
Initiated
January 16, 2023
Classification
Class II
Status
Ongoing
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

Code information

UDI/DI 405686901102894792, Material Number 10532746, Serial Number 94792

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.

device · product 2 of 3

SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile

Z-1135-2023
Recall number
Z-1135-2023
Initiated
January 16, 2023
Classification
Class II
Status
Ongoing
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

Code information

a) Flow 64-4R Seismic, UDI/DI 405686900142560047, Material Number 10529161, Serial Number 60047; b) S(40)-3R Seismic, UDI/DI 405686900131960054, Material Number 10248668, Serial Number 60054; c) S(64)-3R Seismic, UDI/DI 405686900133360091, Material Number 10248669, Serial Number 60091; d) S(40)-4R Seismic, UDI/DI 405686900132660047, Material Number 10248671, Serial Number 60047; e) S(64)-4R Seismic, UDI/DI 405686900134060076, Material Number 10248672, Serial Number 60076; f) S(20)-3R Mobile, UDI/DI 405686900129660028, , Material Number 10534159, Serial Number 60028

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.

device · product 3 of 3

SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge

Z-1136-2023
Recall number
Z-1136-2023
Initiated
January 16, 2023
Classification
Class II
Status
Ongoing
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

Code information

a) 450: UDI/DI 405686923807410106, Material Number 10749669, Serial Number 10106; b) 600: UDI/DI 405686922450311120, Material Number 10749670, Serial Number 11120; UDI/DI 405686922450311116, Material Number 10749670, Serial Number 11116; c) 600 Edge: UDI/DI 405686918321311068, Material Number 10749672, Serial Number 11068

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.