Siemens Medical Solutions USA, Inc. 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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Siemens Medical Solutions USA, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Siemens Medical Solutions USA, Inc. is recalling The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Loo due to 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 exp. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm issued undated letters flagged Customer Safety Advisory Notice CAN 001-2023 on 7/12/2023 via email, certified mail, or, if necessary, hand delivery. The letter explains the issue, when the malfunction occurs, the potential risks, and how the consignee can help to avoid the potential risk of the issue. The letter informs the consignee that Siemens Healthineers is working to address the issue through a scheduled service visit and the consignee's local service organization will begin contacting the consignees in the 4th quarter of 2023 to schedule this work. In the meantime, the notice is to be placed in the Symbia Pro.specta Operator Manual and disseminated to all operators of the scanner. No response form was enclosed. The recalling firm uses an SAP system for tracking purposes. For the letters that are delivered via email, the consignee verifies receipt through an adobe signature. For the letters delivered via certified mail, there is a return receipt.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
ID, KS, MA, NH, OH, TX, VA
Page updated: Jan 10, 2026