TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; T
FDA device recall Z-1113-2014 · posted 2014-03-03 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- Reason for recall
- Toshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software, the X-ray output conditions may not be set correctly. As a result, X-ray exposure under the scan conditions used for contrast study may not start.
- Action taken
- Toshiba sent an Urgent Medical Device Correction letter on October 1, 2013, via USPS return receipt mail and accompanied by a response form. The recall notification letter provided the Device Model, serial number, SID, problem, corrective action, request to customers, and contact information (800) 421-1968 or (800) 521-1968. Toshiba designed and test an upgraded ROM for the SC2 PWB to prevent recurrence of the fault. Service technicians will replace the ROM on site at no cost to the system owners. All repairs are expected to be completed by April 2014 and progress reports will be provided on the effectiveness of the plan. For questions regarding this recall call 714-730-5000.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 338 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-10-01
- Date posted
- 2014-03-03
- Date terminated
- 2015-03-03
- Location
- Tustin, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AQUILION RXL (K121553) | Toshibamedical Systems Corporation | 2012-07-26 |
| AQUILION ONE (K113466) | Toshiba Medical Systems Coporation, Japan | 2012-04-10 |
| MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM (K080211) | Toshiba America Medical Systems, In.C | 2008-03-14 |