Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
- Recall Initiated
- March 11, 2022
- Terminated
- April 14, 2023
- Recall Number
- Z-0893-2022
- Quantity
- 7 devices
- Firm Location
- Hoffman Estates, IL
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
Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.
Lot / Code Info
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)
Root Cause
Nonconforming Material/Component
Action Taken
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.