The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam s
FDA device recall Z-0651-2014 · posted 2014-01-09 · Terminated
Recall details
- Recalling firm
- Midmark Corp dba Progeny Inc
- Reason for recall
- 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").
- Action taken
- 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 purchased any defective units. Field corrections include the upgrading of RTC firmware to revision 3.4 on the defective units and will be performed as no additional charge by Midmark personnel. Letter sent to practitioners include instructions on how to identify the defective units, instructions on how to temporarily reduce the likelihood of the unintentional movement, and to contact Midmark at 847-415-9739 or via- e-mail at abavuso@midmark.com. Midmark will schedule an on-site field correction by upgrading the firmware to revision 3.4.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUH
- Quantity affected
- 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,
- Date initiated
- 2013-09-20
- Date posted
- 2014-01-09
- Date terminated
- 2017-12-27
- Location
- Lincolnshire, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VANTAGE MODEL V5000, V5100, V5000C, V5100C (K122643) | Midmark Corp. | 2013-01-07 |