Reported Nov 1, 2017 · Terminated
Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc. · 2501 Barrington Rd · Hoffman Estates, IL · 60192-2061
Is this the product you have?
- 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.
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 Symbia T2 serial number 2001 2 Symbia Intevo Excel serial numbers 2112 and 2140 3 Symbia Intevo 16 serial numbers 2100 and 2116 4 Symbia Evo serial numbers 1049, 1054, 1071, 1075, 1104, and 1128 5 and Symbia Evo Excel serial numbers 1109, 1111, 1131, 1134, and 1158. - Amount recalled
- 16 devices
Where it was sold
Why it was recalled
The torque wrench used to tighten system bolts during installation was found to be out of tolerance
This product could cause temporary or reversible health problems — stop using it.
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