Home / Recalls / Siemens Medical Solutions USA, Inc. / Z-0893-2022

Z-0893-2022 Class II Terminated

Recalled by Siemens Medical Solutions USA, Inc. — Hoffman Estates, IL

FDA device recall Z-0893-2022 was initiated by Siemens Medical Solutions USA, Inc. on Mar 11, 2022 and is designated Class II. Reason for recall: There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue. The recall status is terminated (terminated Apr 14, 2023). Affected quantity: 7 devices.

Recall Details

Product Type: Devices
Report Date: Apr 13, 2022
Initiation Date: Mar 11, 2022
Termination Date: Apr 14, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7 devices

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.

Distribution Pattern

Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.

Code Information

A) Symbia Intevo Bold system; Model Number 11007962; Serial Numbers: 1) 1499 (UDI:40568690011591499) 2) 1501(UDI: 40568690011591501) 3) 1505 (UDI: 40568690011591505) 4) 1510 (UDI: 40568690011591510) B) Symbia Intevo 6 system; Model Number 10764803; Serial Numbers: 1) 2352 (UDI: 40568690012342352) 2) 2353 (UDI: 40568690012342353) 3) 2354 (UDI: 40568690012342354)

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0893-2022
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.