Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluorosco
FDA device recall Z-1714-2014 · posted 2014-06-04 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- Reason for recall
- Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, the movement of longitudinal tilt does not stop.
- Action taken
- Toshiba America Medical Systems, Inc. initiated this recall by sending recall notifications via USPS return receipt mail. The recall notification letter, dated May 12, 2014, titled "URGENT: MEDICAL DEVICE CORRECTION", informed customers of the following: device information, serial number, SID, reason for reason, purpose of the notification, corrective action, request to customers, contact information, and customer reply form. Customers with questions regarding this letter were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968. For questions regarding this recall call 714-730-5000.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 2
- Distribution
- Nationwide Distribution including CA and IN
- Date initiated
- 2014-05-12
- Date posted
- 2014-06-04
- Date terminated
- 2014-10-02
- Location
- Tustin, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFX-8000V WITH (K120073) | Toshibamedical Systems Corporation | 2012-01-26 |