Siemens Medical Solutions USA, Inc. Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
Brand
Siemens Medical Solutions USA, Inc.
Lot Codes / Batch Numbers
A) Symbia Intevo Bold system, Model Number 11007962, Model Number 10764803
Products Sold
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)
Siemens Medical Solutions USA, Inc. is recalling Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems due to There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
Recommended Action
Per FDA guidance
Customer Advisory Notice Letter will be provided to each impacted consignee. Depending on the customer s capabilities, Siemens provides the letters via mail, e-mail, or hand delivery by a service engineer. The receipt of the letter will be documented, and additional attempts will be made until such receipt is acknowledged. The safety advisory letter informs customers: You may continue to use your system ensuring to follow all instructions in the Operator Manual. If any changes in system vibrations or noises are detected, then activate the Emergency Stop (E-Stop), discontinue use of the system immediately and contact your service engineer.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026