Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic proc
FDA device recall Z-0994-2013 · posted 2013-03-25 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- Reason for recall
- Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option in the "manual mode" an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may be lost requiring additional image acquisitions to be performed.
- Action taken
- In November, 2012, Toshiba America Medical Systems, Inc. sent an Urgent: Medical Device Correction letter to customers. The letter contains a return reply form that is to be faxed to TAMS for retention.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 95 units
- Distribution
- USA nationwide. No international.
- Date initiated
- 2012-11-08
- Date posted
- 2013-03-25
- Date terminated
- 2013-03-26
- Location
- Tustin, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFX-8000V WITH (K120073) | Toshibamedical Systems Corporation | 2012-01-26 |
| INFINIX-CCI (K113052) | Toshiba America Medical Systems, In.C | 2011-11-22 |
| INFX-8000F (INFINIX CSI AND INFINIX DPI) (K081624) | Toshiba America Medical Systems, In.C | 2008-06-23 |
| MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR (K052884) | Toshiba America Medical Systems, In.C | 2005-10-26 |