The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sens

FDA device recall Z-2256-2023 · posted 2023-07-28 · Open, Classified

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc.

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.

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

KPS

Quantity affected

108 systems

Distribution

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, Denma

Date initiated

2023-07-12

Date posted

2023-07-28

Location

Hoffman Estates, IL

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