The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1135-2023·Announced 2023-02-22

Potential Gantry Locking Mechanism Defect in SIEMENS Biograph mCT PET Scanners

The SIEMENS Biograph mCT PET scanner has a potential issue with the locking mechanism that secures the gantry. Six units distributed worldwide including the US, Japan, Chile, and Australia are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving a potential failure of a safety component (the locking mechanism) that secures heavy imaging equipment. No injuries have been reported, but this constitutes a risk-of-harm product where injury has not yet been reported, meeting the criterion for a High severity rating.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling six SIEMENS Biograph mCT PET scanner models due to a potential problem with the locking mechanism that secures the PET gantry in either its scanning or service position. The affected models are Flow 64-4R Seismic, S(40)-3R Seismic, S(64)-3R Seismic, S(40)-4R Seismic, S(64)-4R Seismic, and S(20)-3R Mobile.

The affected scanners have been distributed worldwide to medical facilities in the United States, Japan, Chile, and Australia. Healthcare facilities that may have one of these devices should verify whether their equipment is part of this recall using the provided identification information, including UDI numbers and serial numbers for each model.

Facilities with affected units should contact Siemens Medical Solutions USA, Inc. for guidance on addressing the locking mechanism issue. Equipment should not be used until the manufacturer or an authorized service representative has resolved the issue.

The recalled product

Product
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
Manufacturer
Siemens Medical Solutions USA, Inc.
Category
Medical Device — Diagnostic Imaging Equipment
Hazard
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • e) S(64)-4R Seismic
  • UDI/DI 405686900134060076
  • Material Number 10248672
  • Serial Number 60076
  • f) S(20)-3R Mobile

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Siemens Medical Solutions USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Siemens Medical Solutions USA, Inc.

See all →

Same hazard · mechanical failure

See all →

Similar recalls