Recall Z-2256-2023 ยท KPS System, Tomography, Computed, Emission
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.
| Date | Jul 28, 2023 (initiated Jul 12, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 notic |
| Quantity | 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, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Netherlands, Portugal, Singapore, S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212604 | Symbia VA10A Family Siemens Medical Solutions USA, Inc., Sep 16, 2021 |