Recall Z-0941-2012 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Toshiba American Medical Systems Inc
DRAD-3000E: Radrex-i X-ray is a general purpose X-ray System. Labeling reads in part "TOSHIBA***DIGITAL RADIOGRAPHY SYSTEM RADREX-i DRAD-3000E Systems Data No. MSDXR0144EA***"
| Date | Feb 2, 2012 (initiated Dec 29, 2011) |
| Status | Terminated |
| Reason | It has been found that some of the starter cables used for x-ray tube high speed rotation are not sufficiently durable. |
| Root cause | Nonconforming Material/Component |
| Action | The recall notification titled "URGENT: MEDICAL DEVICE CORRECTION", was sent on 12/29/11 to customers via certified mail. The letter informed the customer of an issue with the starter cable used for high speed rotation on the Radrex X-Ray System. The letter also informs customers of the corrective measures: a replacement cable will be installed on your system to prevent this issue from occurring. An 800 number was provided for any questions regarding the letter. |
| Quantity | 39 |
| Distribution | Class II Recall - Nationwide Distribution (USA) - Including the states of VA, IL, CA, PA, TN, OH, LA, TX, OK, AR, AZ, MS, WV, TN, WI, NJ, MN, NY, IA, FL, and Washington D.C. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083503 | DRAD30003/RADREX-I Toshiba America Medical Systems, In.C, Feb 13, 2009 |