Recall Z-2256-2023— Siemens Medical Solutions USA, Inc.
Class II · Ongoing
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2023-07-12. It names one FDA 510(k) clearance: K212604. 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.. 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..
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-12
- Firm location
- Hoffman Estates, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.