Recall Z-1135-2023— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-1135-2023
Creator: U.S. Food and Drug Administration
Published: 2023-01-16

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2023-01-16. It names one FDA 510(k) clearance: K193248. 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. Reason: This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-01-16
Firm location: Hoffman Estates, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K193248 — Biograph Vision, Biograph mCT Family of PET/CTsSiemens Medical Solutions USA, Inc.·cleared 2020-02-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.