Z-1340-2013Class II

Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a...

Name: Z-1340-2013 Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a...
Creator: Linvatec Corp. dba ConMed Linvatec
Published: 2013-03-18
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2013-03-18 / Terminated / root cause: software

FDA source

Linvatec Corp. dba ConMed Linvatec began a recall of Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical... on 2013-03-18. FDA classified it as Class II and gives the reason as "The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code in the VP1600 console and the communications interface for various keyboard key strokes (Caps lock and Num Lock) which may...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1340-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-18
Posted: 2013-05-20
Terminated: 2013-11-06
Recalling firm: Linvatec Corporation
Product: Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures.
Product code: KQM Camera, Surgical And Accessories
Reason for recall: The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code in the VP1600 console and the communications interface for various keyboard key strokes (Caps lock and Num Lock) which may lock up and requires the user to reboot to continue.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: The firm, ConMed, sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated 3/8/2013 to its customers after initial phone notifications. The letter identified the product, problem, and actions to be taken by the customers.
Quantity in commerce: 267 units
Distribution: Worldwide Distribution-USA (nationwide) including the Virgin Islands and the states of CA, CT, FL, GA, IN, KY, KS, LA, MD, MI, MN, MO, MS, MT, NE, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, and WI, and the countries of Austria, Belgium, Canada, Denmark, Hong Kong and Zambia.
Product codes and lots: VP1600

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1340-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1340-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-20

Product code KQM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)