Recall Z-0893-2022— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-0893-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-11

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2022-03-11, terminated 2023-04-14. It names one FDA 510(k) clearance: K200474. Product: Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems. Reason: There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-03-11
Terminated: 2023-04-14
Firm location: Hoffman Estates, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K200474 — Symbia 6.7Siemens Medical Solutions USA, Inc.·cleared 2020-03-20

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

Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems

Reason for recall

There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.

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