GETINGE recalls VOLISTA StandOP Surgical Lights with model numbers VLT600 SF AIM STP and VLT600 DF AIM STP due to handle holder detaching during use, risking particles falling into the sterile surgical field.
The manufacturer received complaints indicating that the device's central handle holder detaches easily from the handle holder ring on the light head during clinical use. In the event of such detachment, particles from the handle holder ring could fall into the sterile field during a procedure.
GETINGE is recalling certain VOLISTA StandOP Surgical Lights because the handle holder can detach during surgery, potentially causing particles to fall into the sterile field. This poses a risk of contamination during procedures.
The handle holder ring on the light head can detach easily during clinical use. If this happens, small particles from the ring may fall into the sterile surgical field, potentially contaminating the procedure site.
Healthcare professionals using the recalled surgical lights in hospitals, clinics, or outpatient settings are most at risk. Patients undergoing surgery with these lights could be exposed to contaminants.
Check for model numbers VLT600 SF AIM STP or VLT600 DF AIM STP with serial numbers listed in the recall notice. The device is sold in surgical suites, clinics, and outpatient facilities.
Identify the model number on your VOLISTA StandOP Surgical Light to see if it matches VLT600 SF AIM STP or VLT600 DF AIM STP.
Reach out to GETINGE US SALES LLC for guidance on next steps if your device is affected.
The manufacturer received complaints that the handle holder can detach during surgery, risking particles falling into the sterile field.
Check the model number and serial numbers against the recall list. Contact GETINGE US SALES LLC for further instructions.
Yes, if the handle holder detaches, particles from the ring could fall into the surgical field, potentially contaminating the procedure.
We’ve drafted a message you can send GETINGE to request your refund or repair — edit it as you like.
Subject: Recall Z-1349-2018 — GETINGE GETINGE Hello, I own a GETINGE that is covered by recall Z-1349-2018 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.
