The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1136-2023·Announced 2023-02-22

Siemens Biograph Vision PET Scanner Gantry Locking Mechanism Recall

Siemens recalls Biograph Vision PET scanners worldwide for a potential defect in the gantry locking mechanism that secures the equipment during scanning and service.

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 Class II medical device recall addresses a structural defect in a locking mechanism that could compromise equipment stability and create risk of harm to healthcare workers and patients. No incidents or injuries have been reported, but the mechanical failure poses a real safety risk.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling Biograph Vision PET scanners in three models: 450, 600, and 600 Edge. Four units have been distributed worldwide to locations in the United States, Japan, Chile, and Australia.

The recall has been issued for a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position. This mechanism is essential to keeping the scanner properly positioned during use and maintenance.

Healthcare facilities that may have received any of the recalled scanners should verify whether their equipment matches the provided serial numbers and material numbers. Affected facilities should contact Siemens Medical Solutions USA, Inc. to request instructions and support for addressing this issue.

The recalled product

Product
SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
Manufacturer
Siemens Medical Solutions USA, Inc.
Category
Medical Device — Diagnostic Imaging Equipment
Hazard
Affected units
4

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 (11)

  • 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
  • Serial Number 11116
  • c) 600 Edge: UDI/DI 405686918321311068
  • Material Number 10749672
  • Serial Number 11068

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 →

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