FDA recall record

Richard Wolf Medical Instruments The Vesa 75/100 adaptation with rotation is an accessory to recall — FDA Z-1188-2016

Supplier of the "VESA 75 / 100 adaptation with rotation", which is part of their monitor mounts and support arms may be missing riveting.

Class IIclassification
Z-1188-2016official record ID
Mar 23, 2016report date

Recall record at a glance

Official recordZ-1188-2016
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmRichard Wolf Medical Instruments Corp.
Report dateMar 23, 2016
Recall initiation dateFeb 29, 2016
Quantity108 units
LocationVernon Hills, IL, United States

Official product description

The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record operative procedures.

Why the product was recalled

Supplier of the "VESA 75 / 100 adaptation with rotation", which is part of their monitor mounts and support arms may be missing riveting.

Distribution information

Nationwide Distribution including Virginia, Pennsylvania, Florida, California, Texas, North Carolina and Illinois.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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