Recalls / —
—#158972
Product
Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices.
- FDA product code
- KPS — System, Tomography, Computed, Emission
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K162337
- Affected lot / code info
- Symbia T2 serial number 2001; Symbia Intevo Excel serial numbers 2112 and 2140; Symbia Intevo 16 serial numbers 2100 and 2116; Symbia Evo serial numbers 1049, 1054, 1071, 1075, 1104, and 1128; and Symbia Evo Excel serial numbers 1109, 1111, 1131, 1134, and 1158.
Why it was recalled
The torque wrench used to tighten system bolts during installation was found to be out of tolerance
Root cause (FDA determination)
Equipment maintenance
Action the firm took
The recall was initiated via phone and visit beginning 9/18/2017.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc.
- Address
- 2501 Barrington Rd, Hoffman Estates, Illinois 60192-2061
Distribution
- Distribution pattern
- Distribution was made to medical facilities located in CA, FL, GA, LA, NY, PA, and TN. There was government distribution but no foreign/military distribution.
Timeline
- Recall initiated
- 2017-09-18
- Terminated
- 2017-12-11
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #158972. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.