Z-2256-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 9, 2023
- Initiation Date
- July 12, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 108 systems
Product Description
The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753.
Reason for Recall
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.
Distribution Pattern
Distribution was made to ID, KS, MA, NH, OH, TX, and VA. There was no government/military distribution. Foreign distribution was made to Argentina, Australia, Austria, Belgium, Canada, Colombia, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Netherlands, Portugal, Singapore, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
Code Information
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: 100223, 100225, 100227, 100228, 100237; Additional serial numbers as of 10/17/2023: 100214, 100229; Additional serial numbers as of 12/12/2023: 100232, 100231, 100234; Additional serial number as of 01/15/2024:100226. (b) Serial numbers 100101, 100102, 100201, 100203, 100204, 100207, 100206, 100208, 100205, 100209, 100210, 100212, 100213, 100214, 100215, 100216, 100218, 100217, 100219, 100220, 100221, 100223, 100224, 100222, 100226, 100228, 100227, 100225, 100229, 100231, 100232, 100233, 100235, 100234, 100237, 100239, 100241, 100240, 100236, 100238, 100242, 100243, 100247, 100244, 100250, 100251, 100252, and 100255; UDI-DI 4056869264752; Additional serial numbers as of 09/07/2023: 100245, 100256, 100257, 100258, 100261, 100262, 100265, 100273; Additional serial numbers as of 10/17/2023: 100230, 100266; Additional serial numbers as of 12/12/2023: 100269; Additional serial numbers as of 01/15/2024: 100248, 100254, 100260, 100271, 100272. (c) Serial numbers 100101, 100201, 100203, 100202, 100205, and 100206; UDI-DI 4056869264769; Additional serial numbers as of 09/07/2023: 100208, 100210; Additional serial numbers as of 12/12/2023: 100209