Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers RO
Summary
The FDA issued a Class II for Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light Syst by Getinge Usa Sales Inc. Reason: A potential for a light system to fall in the operating room..
Details
Source
Device Recall
External ID
Z-0758-2024
Action Date
2024-01-24
Status
Ongoing
Category
device
Product Description
Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF STP - ARDROL309001A, ROL B FOR VLT400SF STP - ARDROL309001C, ROL B FOR VLT600SF STP - ARDROL309003A, ROL B FOR VLT600SF STP - ARDROL309003C, ROL FOR VLT400SF STP - ARDROL309000A, ROL FOR VLT400SF STP - ARDROL309000C, ROL FOR VLT600SF STP - ARDROL309002A, ROL FOR VLT600SF STP - ARDROL309002C, VCS40 ROL - ARDROL309024A, VCS40 ROL - ARDROL309024C, VCS40 ROL - ARDROL309028A, VCS40 ROL - ARDROL309028C, VCS60 ROL - ARDROL309025A, VCS60 ROL - ARDROL309025C, VCS60 ROL - ARDROL309029A, VCS60 ROL - ARDROL309029C, VST40 - ARDROL309016A, VST40 - ARDROL309016C, VST40 - ARDROL309017A, VST40 - ARDROL309017C, VST40 - ARDROL309020A, VST40 - ARDROL309020C, VST40 - ARDROL309022A, VST40 - ARDROL309022C, VST60 - ARDROL309018A, VST60 - ARDROL309018C, VST60 - ARDROL309019A, VST60 - ARDROL309019C, VST60 - ARDROL309021A, VST60 - ARDROL309021C, VST60 - ARDROL309023A, VST60 - ARDROL309023C, VCS40DF - ARDVCS209001A, VCS40DF - ARDVCS209001C, VCS40DF - ARDVCS209010A, VCS40DF - ARDVCS209012A, VCS40DF - ARDVCS209021A, VCS40SF - ARDVCS209000A, VCS40SF - ARDVCS209000C, VCS40SF - ARDVCS209011A, VCS40SF 08 - ARDVCS209046A, VCS44DF - ARDVCS209005A, VCS44DF - ARDVCS209005C, VCS44DF - ARDVCS209016A, VCS44SF - ARDVCS209004A, VCS44SF - ARDVCS209004C, VCS44SF - ARDVCS209015A, VCS44SFDF - ARD2VCS00040A, VCS60DF - ARDVCS209003A, VCS60DF - ARDVCS209003C, VCS60DF - ARDVCS209014A, VCS60DF - ARDVCS209022A, VCS60DF 11 - ARDVCS209047A, VCS60SF - ARDVCS209002A, VCS60SF - ARDVCS209002C, VCS60SF - ARDVCS209013A, VCS64DF - ARDVCS209007A, VCS64DF - ARDVCS209007C, VCS64DF - ARDVCS209018A, VCS64SF - ARDVCS209006A, VCS64SF - ARDVCS209006C, VCS64SF - ARDVCS209017A, VCS64SFDF - ARD2VCS00010A, VCS64SFDF 1011 - ARDVCS209048A, VCS66DF - ARDVCS209009A, VCS66DF - ARDVCS209009C, VCS66DF - ARDVCS209020A, VCS66SF - ARDVCS209008A, VCS66SF - ARDVCS209008C, VCS66SF - ARDVCS209019A, VCSII40DF SB08 - ARDVCS209023A, VCSII40DF SB11 - ARDVCS209024A, VCSII40SF SB11 - ARDVCS209025A, VCSII44DF SB0810 - ARDVCS209026A, VCSII44SF SB1011 - ARDVCS209027A, VCSII60DF SB08 - ARDVCS209028A, VCSII60SF SB11 - ARDVCS209029A, VCSII64DF SB0810 - ARDVCS209030A, VCSII64SF SB1011 - ARDVCS209031A, VCSII66DF SB0810 - ARDVCS209032A, VCSII66SF SB1011 - ARDVCS209033A, VCSII40DF TK SB08 - ARDVCS209034A, VCSII40DF TK SB11 - ARDVCS209035A, VCSII40SF TK SB11 - ARDVCS209036A, VCSII44DF TK SB0810 - ARDVCS209037A, VCSII44SF TK SB1011 - ARDVCS209038A, VCSII60DF TK SB08 - ARDVCS209039A, VCSII60SF TK SB11 - ARDVCS209040A, VCSII64DF TK SB0810 - ARDVCS209041A, VCSII64SF TK SB1011 - ARDVCS209042A, VCSII66DF TK SB0810 - ARDVCS209043A, VCSII66SF TK SB1011 - ARDVCS209044A, VCS40DF SAT 12 - ARD2VCS00070A, VCSII40SF SB08 - ARDVCS209049A, VCSII64SFDF SB1011 - ARDVCS209050A, SAT VLT400D - ARD2SAT00080C, SAT VLT400D - ARD2SAT00100C, SAT VLT400DF - ARD2SAT00080A, SAT VLT400DF - ARD2SAT00100A, SAT VLT400S - ARD2SAT00030C, SAT VLT400S - ARD2SAT00040C, SAT VLT400SF - ARD2SAT00040A, SAT VLT40DF - ARD268800130A, SAT VLT40DF - ARD268800130C, SAT VLT40SF - ARD268800120A, SAT VLT40SF - ARD268800120C, SAT VLT60DF - ARD2SAT00170A, SAT VLT60DF - ARD2SAT00170C, SAT VLT60SF - ARD2SAT00180C, SAT VST40DF - ARDSAT209018A, SAT VST40DF - ARDSAT209019A, SAT VST40DF - ARDSAT209022A, SAT VST40DF - ARDSAT209023A, SAT VST40SF - ARDSAT209010A, SAT VST40SF - ARDSAT209011A, SAT VST40SF - ARDSAT209014A, SAT VST40SF - ARDSAT209015A, SAT VST60DF - ARDSAT209034A, SAT VST60DF - ARDSAT209035A, SAT VST60DF - ARDSAT209038A, SAT VST60DF - ARDSAT209039A, SAT VST60SF - ARDSAT209026A, SAT VST60SF - ARDSAT209027A, SAT VST60SF - ARDSAT209030A, SAT VST60SF - ARDSAT209031A, STANDOP 40DF SINGLE - ARDSTP229005A, STANDOP 40SF SINGLE - ARDSTP229000A, STANDOP 44DF DOUBLE - ARDSTP229007A, STANDOP 44SF DOUBLE - ARDSTP229002A, STANDOP 60DF SINGLE - ARDSTP229006A, STANDOP 60SF SINGLE - ARDSTP229001A, STANDOP 64DF DOUBLE - ARDSTP229008A, STANDOP 64SF DOUBLE - ARDS
Lot/Code Info: All systems affected UDI-DI: 03700712400798 03700712400804 03700712400811 03700712400828 03700712400835 03700712400842 03700712400859 03700712400866 03700712400873 03700712400880 03700712400897 03700712400903
Quantity Affected: 236793 units in total
Reason for Recall
A potential for a light system to fall in the operating room.
Distribution
US Nationwide. Global Distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-08
Company
Wayne, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Getinge Usa Sales Inc has 48 FDA actions in our database, including 48 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Getinge Usa Sales Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Getinge Usa Sales Inc have FDA actions?
Getinge Usa Sales Inc has 48 FDA actions in our database, including 48 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0758-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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