CLASS II Device recall · Reported 1 Nov 2017 · FDA Enforcement Report

Torque wrench used on the bolts for the Symbia T2 recalled

Siemens Medical Solutions USA is recalling Torque wrench used on the bolts for the Symbia T2, distributed in 7 states. The recall was initiated on 18 Sep 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSymbia 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.

Quantity recalled16 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0047-2018
FDA event ID: 78086
Recalling firm: Siemens Medical Solutions USA, Hoffman Estates, IL
Classification: Class II
Status: Terminated
Recall initiated: 18 Sep 2017
FDA classified: 25 Oct 2017
Reported: 1 Nov 2017
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

18 Sep 2017	Recall initiated by company
25 Oct 2017	Classified by FDA	+37 days
1 Nov 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The torque wrench used to tighten system bolts during installation was found to be out of tolerance

Product as listed by the FDA

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.

Where it was distributed

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.

California Florida Georgia Louisiana New York Pennsylvania Tennessee

Questions about this recall

Why was it recalled?

The torque wrench used to tighten system bolts during installation was found to be out of tolerance

Which lots are affected?

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.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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