Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The syste...
FDA Device Recall #Z-2282-2012 - Class II, July 13, 2009
Recall Summary
| Recall Number | Z-2282-2012 |
| Classification | Class II - Moderate risk |
| Date Initiated | July 13, 2009 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Toshiba American Medical Systems Inc |
| Location | Tustin, CA |
| Product Type | Devices |
| Quantity | 24 Systems |
Product Description
Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.
Reason for Recall
1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reco
Distribution Pattern
Nationwide distribution: USA including states of: AL, AR, CA, CO, FL, GA, KY, MA, MD, MT, ND, NJ, NV, NY, OH, PA and Puerto Rico.
Lot / Code Information
Serial Number: 2DA0882051
Other Recalls from Toshiba American Medical Systems Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2315-2018 | Class II | Diagnostic Ultrasound System, Aplio I-series. ... | Jan 4, 2018 |
| Z-0843-2018 | Class II | INFX-8000C Fluoroscopic X-Ray Systems | Dec 29, 2017 |
| Z-0842-2018 | Class II | INFX-8000F Fluoroscopic X-Ray Systems | Dec 29, 2017 |
| Z-0845-2018 | Class II | INFX-8000H Fluoroscopic X-Ray Systems | Dec 29, 2017 |
| Z-0844-2018 | Class II | INFX-8000V Fluoroscopic X-Ray Systems; INFINIX ... | Dec 29, 2017 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.