Reported Jan 15, 2014 · Terminated
The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam…
Midmark Corp. dba Progeny Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Midmark Corp dba Progeny Inc · 675 Heathrow Dr · Lincolnshire, IL · 60069-4206
Is this the product you have?
- 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
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Product as published V50000, 3.1, 3.2, and 3.3. Vantage Panoramic X-Ray System Catalog Numbers and Serial Numbers: , 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 V5050Serial Number ZZ08014 V5100Serial Numbers ZM81027, ZM81028, ZZ08003 V5150Serial Number ZZ08002 V5150CSerial Number ZM81016 - Amount recalled
- 58 units
Where it was sold
Why it was recalled
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").
This product could cause temporary or reversible health problems — stop using it.
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