Getinge recalls VOLISTA StandOP Surgical Lights with certain product codes due to risk of paint particles detaching during surgery, potentially causing infection or tissue reactions. Affected units include specific model numbers and serial ranges.
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.
Getinge is recalling certain VOLISTA StandOP Surgical Lights because paint particles may detach and fall into the operating field during surgery. If these particles enter the patient, they could cause infection, organ irritation, or other serious reactions.
Paint particles can detach from the surgical light during operation and fall into the patient's body or the surgical field. This may lead to infection, organ irritation, hypersensitivity reactions, or tissue granulomas if particles enter the patient.
Surgical teams using the recalled VOLISTA StandOP Surgical Lights are most at risk. Patients undergoing surgery with these lights could be exposed to paint particles.
Check for product codes ARD568811901, ARD568811911, ARD568811961, ARDVST229000A, ARDVST229001A, ARDVST229002A, ARDVST229003A, ARDVST229034A, ARDVST229036A, or ARDVST229037A. Also check serial numbers listed in the recall notice.
Review the product codes listed in the recall notice to confirm if your surgical light is affected.
Reach out to Getinge directly for assistance with the recall process or to confirm if your unit is affected.
Product codes ARD568811901, ARD568811911, ARD568811961, ARDVST229000A, ARDVST229001A, ARDVST229002A, ARDVST229003A, ARDVST229034A, ARDVST229036A, and ARDVST229037A are affected.
Check the product code or serial number on your light against the list provided in the recall notice.
Contact Getinge directly to confirm if your unit is affected and to receive guidance on next steps.
We’ve drafted a message you can send Getinge to request your refund or repair — edit it as you like.
Subject: Recall Z-1308-2022 — Getinge Getinge Hello, I own a Getinge that is covered by recall Z-1308-2022 from Getinge. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
