Recall record at a glance
| Official record | Z-1308-2022 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Getinge Usa Sales Inc. |
| Report date | Jul 6, 2022 |
| Recall initiation date | May 6, 2022 |
| Quantity | 337 (US); 8594 (OUS) |
| Location | Wayne, NJ, United States |
Official product description
VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST229001A VST60DF AIM ARDVST229002A VST66SF AIM ARDVST229003A VST66DF AIM ARDVST229034A VST60SF ARDVST229036A VST66SF ARDVST229037A VST66DF
Why the product was recalled
Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical operation into the patient body or in the operating field.
Distribution information
Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, CT, GA, IA, ID, KS, KY, LA, MA, MD, ME, MO, NE, NY, OH, OR, TN, TX, UT, VA, WA.
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
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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