FDA Adverse Event Malfunction Summary report: N

VIX WIN SOFTWARE

MDR report key: 2738670 · Received September 6, 2012

Report

Report Number: 2530069-2012-00022
Event Type: Malfunction
Date Received: September 6, 2012
Date of Event: August 8, 2012
Report Date: August 8, 2012
Manufacturer: IMAGING SCIENCES INTERNATIONAL, LLC DBA GENDEX DENTAL SYSTEMS
Product Code: LLZ
PMA / PMN Number: K060178
Removal / Correction Number: Z-1548-2009
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: DENTIST

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER IS USING (B)(4). (B)(4) IS NOT COMPATIBLE WITH SOFTDENT V14.1 OR THE GENDEX GXS 700 SENSORS. ON (B)(4) 2009, GENDEX DENTAL SYSTEMS CONDUCTED A VOLUNTARY RECALL OF THE (B)(4), STATING ISSUES WITH THE PRACTICE MANAGEMENT SOFTWARE AS IT INTERFACES WITH SOFTDENT MANAGEMENT SYSTEM RELATING TO PT DATA MIX UPS. THIS RECALL WAS FDA TERMINATED ON (B)(4) 2011. THE CORRECTION TO THIS RECALL WAS TO UPDATE THE (B)(4). OUR DISTRIBUTOR (B)(4) WAS NOTIFIED ON TWO OCCASIONS AND ACKNOWLEDGED BOTH TIMES OF THIS RECALL. (B)(4) SENT A RECALL NOTIFICATION TO (B)(6) ON (B)(6) 2010 WITH INSTRUCTIONS ON HOW TO CORRECT THE ISSUE WITH AN UPGRADE TO (B)(4). IF ASSISTANCE WAS NEEDED, THE CUSTOMER WAS DIRECTED TO CALL GENDEX TECHNICAL SUPPORT AT (B)(4). THE CUSTOMER'S SOFTWARE WAS UPGRADED TO VERSION 2.0 ON (B)(4) 2012. TECHNICAL SUPPORT IS CURRENTLY WORKING WITH THIS CUSTOMER TO CORRECT THE ISSUE. THERE WAS NO PT OR USER INJURY ASSOCIATED WITH THIS EVENT.

Description of Event or Problem · 1

(B)(4) SOFTWARE IS PLACING IMAGING IN THE WRONG PT CHART.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VIX WIN SOFTWARE	PICTURE ARCHIVING AND COMMUNICATIONS	LLZ	IMAGING SCIENCES INTERNATIONAL, LLC DBA GENDEX DENTAL SYSTEMS	VERSION 1.1

Patients

Seq	Age	Sex	Outcome	Treatment
1