CLASS II Device recall · Reported 13 Apr 2022 · FDA Enforcement Report

Symbia Intevo Bold and Symbia Intevo 6 Spect/CT Systems recalled

Siemens Medical Solutions USA is recalling Symbia Intevo Bold and Symbia Intevo 6 Spect/CT Systems. The recall was initiated on 11 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesA) 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)

Quantity recalled7 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-0893-2022
FDA event ID: 89790
Recalling firm: Siemens Medical Solutions USA, Hoffman Estates, IL
Classification: Class II
Status: Terminated
Recall initiated: 11 Mar 2022
FDA classified: 7 Apr 2022
Reported: 13 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

11 Mar 2022	Recall initiated by company
7 Apr 2022	Classified by FDA	+27 days
13 Apr 2022	Published in enforcement report	+6 days

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

Reason for recall

There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.

Product as listed by the FDA

Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems

Where it was distributed

Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.

Questions about this recall

Why was it recalled?

There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.

Which lots are affected?

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)

Where was it sold?

Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.

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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