Food, drugs, devices › Maquet Cardiovascular Us Sales, Llc
Device recall: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
FDA enforcement event 82978 is a device recall by Maquet Cardiovascular Us Sales, Llc of Wayne, NJ, initiated 28 May 2019 and classified Class II, with 13 product records.
FDA defines Class II as 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. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 10 Jul 2023. Initiation: voluntary: firm initiated. Maquet Cardiovascular Us Sales, Llc has 40 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Maquet Cardiovascular Us Sales, Llc, Wayne, NJ.
Reason for recall
"Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection"
Distribution
"Worldwide distribution. US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1852-2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP | 2 units | Class II | Terminated | 3 Jul 2019 |
| Z-1853-2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP | 11 units | Class II | Terminated | 3 Jul 2019 |
| Z-1854-2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP | 65 units | Class II | Terminated | 3 Jul 2019 |
| Z-1855-2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP | 46 units | Class II | Terminated | 3 Jul 2019 |
| Z-1856-2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP | 7 units | Class II | Terminated | 3 Jul 2019 |
| Z-1857-2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM | 2 units | Class II | Terminated | 3 Jul 2019 |
| Z-1858-2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM | 6 units | Class II | Terminated | 3 Jul 2019 |
| Z-1859-2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM | 12 units | Class II | Terminated | 3 Jul 2019 |
| Z-1860-2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM | 11 units | Class II | Terminated | 3 Jul 2019 |
| Z-1861-2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF | 5 units | Class II | Terminated | 3 Jul 2019 |
| Z-1862-2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF | 2 units | Class II | Terminated | 3 Jul 2019 |
| Z-1863-2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF | 9 units | Class II | Terminated | 3 Jul 2019 |
| Z-1864-2019 | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF | 10 units | Class II | Terminated | 3 Jul 2019 |
Context
Other enforcement events for Maquet Cardiovascular Us Sales, Llc
All 40 events for Maquet Cardiovascular Us Sales, Llc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution. US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Jul 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.