Recall Z-0651-2014 ยท MUH System, X-Ray, Extraoral Source, Digital
Midmark Corp dba Progeny Inc
The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including bitewing, minimize exam set-up time and allow routine diagnostic exams to be performed extraorally for improved clinical efficiency and patient experience. - Progeny Clarity Enhanced Filter Set provides superior diagnostic imaging quality - Exclusive Focal Trou
| Date | Jan 9, 2014 (initiated Sep 20, 2013) |
| Status | Terminated |
| Reason | An error was identified in the Real Time Controller (RTC) firmware versions 3.0, 3.1, 3.2, and 3.3 used in Vantage Panoramic X-Ray systems. The error may cause the column of the Vantage Panoramic X-Ray unit to continue moving vertically despite the release of the movement control button (i.e. failure to stop"). |
| Root cause | Software design |
| Action | An URGENT MEDICAL DEVICE FIELD CORRECTION letter dated September 20, 2013 was sent to all consignees. Letters sent to distributors include instructions on how to identify the defective units, to quarantine the machine(s), and to contact Midmark at 847-415-9739 or via- e-mail at abavuso@midmark.com. Midmark will either schedule an on-site field correction or arrange for the replacement of the affected device(s) depending on the customer's preference. Midmark further requested the distributors provide Midmark with the names, addresses, phone numbers, and e-mail addresses of any customers that |
| Quantity | 58 units |
| Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AK, AL, CA, CO, CT, FL, GA, IL, KS, MA, NC, NH, NJ, OH, OK, PA, SC, TN, TX, VA, and WI, and the countries of Australia, Canada, and Russia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122643 | VANTAGE MODEL V5000, V5100, V5000C, V5100C Midmark Corp., Jan 7, 2013 |