FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc.: Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
- Recall number
- Z-0893-2022
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Product
- Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
- Status
- Terminated
- Initiated
- 2022-03-11
- Posted
- not on file
- Terminated
- 2023-04-14
- Reason
- There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 7 devices
- Distribution
- Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.
- Lot, serial or model codes
- 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)
- 510(k) numbers
- ["K200474"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 1000514697
- Firm city
- Hoffman Estates
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28