The Vantage Digital Panoramic System delivers recall
The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including bitewing…
Why was The Vantage Digital Panoramic System delivers 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").
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including bitewing…
- Recalling firm
- Midmark Corp dba Progeny Inc
- 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.
- Recall date
- January 15, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)