The Recall Desk
ModerateFDA (Devices)·Z-0047-2018·Announced 2017-11-01

Siemens Medical Solutions Recalls Torque Wrenches for Symbia CT Devices

Siemens Medical Solutions is recalling 16 torque wrenches used to install Symbia CT scanners because the tools were found to be out of tolerance.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 16 torque wrenches used to tighten system bolts during the installation of specific Symbia CT scanner models. The affected models include the Symbia T2, Symbia Intevo Excel, Symbia Intevo 16, Symbia Evo, and Symbia Evo Excel.

The recall was initiated because the torque wrenches were found to be out of tolerance. This defect could potentially affect the proper tightening of system bolts during device installation.

The affected devices were distributed to medical facilities in California, Florida, Georgia, Louisiana, New York, Pennsylvania, and Tennessee. There was government distribution, but no foreign or military distribution. Specific serial numbers for the affected devices are listed in the agency's recall record.

The recalled product

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.
Affected units
16

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • 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.

Distribution

Distributed in 7 states:

Same manufacturer · Siemens Medical Solutions USA, Inc.

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