ConMed Linvatec VP1600 HD Still Capture System Software Recall
ConMed Linvatec is recalling 267 VP1600 HD Still Capture Systems due to a software anomaly that may cause the device to lock up.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a software lock-up requiring a reboot without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Linvatec Corp. dba ConMed Linvatec is recalling 267 units of the VP1600 HD Still Capture System. This medical device is used to capture, store, and transfer images generated by a medical endoscopic camera system during surgical procedures.
The recall is due to a software anomaly involving the communications interface for specific keyboard key strokes, such as Caps Lock and Num Lock. This issue may cause the system to lock up, requiring the user to reboot the device to continue operations.
The affected units were distributed nationwide in the United States, including the Virgin Islands, and in several international locations including Austria, Belgium, Canada, Denmark, Hong Kong, and Zambia. Users should contact the recalling firm for instructions on how to resolve the software issue.
The recalled product
- Product
- Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures.
- Manufacturer
- Linvatec Corp. dba ConMed Linvatec
- Hazard
- Affected units
- 267
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- VP1600
Distribution
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