Reported Apr 13, 2022 · Terminated
Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
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?
- Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
- Lot codes and dates
9 of 9 products
Products covered by this recall Model / number Product as published 11007962Symbia Intevo Bold system; ; Serial Numbers — 1499 (UDI:40568690011591499) — 1501(UDI: 40568690011591501) — 1505 (UDI: 40568690011591505) — 1510 (UDI: 40568690011591510) 10764803Symbia Intevo 6 system; ; Serial Numbers — 2352 (UDI: 40568690012342352) — 2353 (UDI: 40568690012342353) — 2354 (UDI: 40568690012342354) - Amount recalled
- 7 devices
Why it was recalled
There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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