FDA Device recall Z-0651-2014
The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including…
- FDA Device
- Class II
- terminated
- Published 2014-01-15
On 2014-01-15 the FDA classified a Class II recall of The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including… by Midmark, citing 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 V….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0651-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-20 |
| Published | 2014-01-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Midmark |
| Distribution | US |
Product
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 Trough Alignment reminder assists in consistent patient positioning - Progeny Imaging software included for download on an unlimited number of operatory workstations with no additional costs - Exclusive VantageTrust remote support and training service offered at no charge for the first 60 days of use - Ceph upgradeable for expanded extraoral exam capabilities - The Progeny Vantage Panoramic System s proudly designed and manufactured in the USA; 2013 Midmark Corporation; 675 Heathrow Drive Lincolnshire, IL 60069; 847-415-9800 Toll-free 888-924-3800
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").
Identifiers
| code_info | Vantage Panoramic X-Ray System firmware versions: 3.0, 3.1, 3.2, and 3.3. Vantage Panoramic X-Ray System Catalog Nu…Vantage Panoramic X-Ray System firmware versions: 3.0, 3.1, 3.2, and 3.3. Vantage Panoramic X-Ray System Catalog Numbers and Serial Numbers: Catalog Number V5000, Serial Numbers ZM81025, ZM81026, ZM81030, ZZ08005, ZZ08006, ZZ08007, ZZ08008, ZZ08009, ZZ08010, ZZ08011, ZZ08012, ZZ08013, ZZ08015, ZZ08016, ZZ08017, Z08018, ZZ08019, ZZ08020, ZZ08021, ZZ08022, ZZ08023, ZB51001, ZB51002, ZB51006, ZB51007, ZT18018, ZY49014, ZK58019, ZS54011, ZP01043, ZV78016, ZE09006, ZN44018, ZS59007, ZS59001, ZW15007, ZW34003, ZW34012, ZW34018, ZY49012, ZY49015, ZZ02010, ZM81022, ZS54012, ZE09019, ZM81017, ZT18004, ZT18015, ZN44020, ZE09012, ZM81023, ZT27012; Catalog Number V5050, Serial Number ZZ08014; Catalog Number V5100, Serial Numbers ZM81027, ZM81028, ZZ08003; Catalog Number V5150, Serial Number ZZ08002; Catalog Number V5150C, Serial Number ZM81016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0651-2014%22
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