Reported Aug 9, 2023 · Ongoing
The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical…
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?
The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly
3 of 3 products
| Model / number | Product as published |
|---|---|
11364751 | (a) Symbia Pro.specta Q3 |
11364752 | (b) Symbia Pro.specta X3 |
11364753. | (c) Symbia Pro.specta X7 |
- Lot codes and dates
- Software version VA20A. (a) Serial numbers 100201, 100202, 100203, 100204, 100205, 100206, 100207, 100209, 100208, 100210, 100212, 100211, 100213, 100215, 100217, 100219, 100218, 100220, 100221, and 100224; UDI-DI 4056869264745. Additional
- serial numbers as of 09/07/2023
100223100225100227100228100237Additional
- serial numbers as of 10/17/2023
100214100229Additional
- serial numbers as of 12/12/2023
100232100231100234Additional
- serial number as of 01/15/2024
100226. (b) Serial numbers 100101100102100201100203100204100207100206100208100205100209100210100212100213100214100215100216100218100217100219100220100221100223100224100222100226100228100227100225100229100231100232100233100235100234100237100239100241100240100236100238100242100243100247100244100250100251100252and 100255UDI-DI 4056869264752Additional
- serial numbers as of 09/07/2023
100245100256100257100258100261100262100265100273Additional
- serial numbers as of 10/17/2023
100230100266Additional
- serial numbers as of 12/12/2023100269; Additional
- serial numbers as of 01/15/2024
100248100254100260100271100272. (c) Serial numbers 100101100201100203100202100205and 100206UDI-DI 4056869264769Additional
- serial numbers as of 09/07/2023
100208100210Additional
- serial numbers as of 12/12/2023100209
- Amount recalled
- 108 systems
Where it was sold
Why it was recalled
During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction in image resolution.
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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