Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers LCA 10 - ARD2LCA00040C, LCA 10 - ARDLCA109000C, LCA 10 - ARDLCA109002C, LCA 10 - ARDLCA109006C, LCA 10 - ARDLCA209008A, LCA 10 - ARDLCA209008C, LCA 10 - ARDLCA209009A, LCA 10 - ARDLCA209009C, LCA 10 - ARDLCA209010A, LCA 10 - ARDLCA209010C, LCA 10 - ARDLCA409000C, LCA 10 - ARDLCA409001C, LCA 10 - ARDLCA409002A, LCA 10 - ARDLCA409002C, LCA 10 - ARDLCA409003C, LCA 10 - ARDLCA409004A, LCA 10 - ARDLCA409004C, LCA 10 - ARDLCA409005C, LCA 10 DES - ARDLCA409001A, LCA 10 MOBILE - ARDLCA309008A, LCA 10 RAIL - ARDLCA409005A, LCA 10 WALL - ARDLCA109006A, LCA 40 - ARDLCA109001C, LCA 40 - ARDLCA208000A, LCA 40 - ARDLCA208000C, LCA 40 - ARDLCA208001A, LCA 40 - ARDLCA208001C, LCA 40 - ARDLCA209000A, LCA 40 - ARDLCA209000C, LCA 40 - ARDLCA209001A, LCA 40 - ARDLCA209001C, LCA 40 - ARDLCA209002A, LCA 40 - ARDLCA209002C, LCA 40 - ARDLCA209003A, LCA 40 - ARDLCA209003C, LCA 40 - ARDLCA209014A, LCA 40 - ARDLCA209014C, LCA 40 - ARDLCA209017A, LCA 40 - ARDLCA209017C, LCA 40 - ARDLCA209018A, LCA 40 - ARDLCA209018C, LCA 40 - ARDLCA209019A, LCA 40 - ARDLCA209019C, LCA 40 - ARDLCA209020A, LCA 40 - ARDLCA209020C, LCA 40 - ARDLCA209021A, LCA 40 - ARDLCA209021C, LCA 40 MOBILE - ARDLCA309009A, LCA 40 WALL - ARDLCA109001A, LCA 40GS - ARDLCA109009A, LCA 40GS - ARDLCA109009C, LCA 100 - ARDLCA109005A, LCA 100 - ARDLCA109005C, LCA 100 - ARDLCA219000A, LCA 100 MOBILE - ARDLCA309006A, LCA 100 MOBILE B - ARDLCA309007A, LCA 100 SAT - ARDSAT209004A, LCA 100 SAT - ARDSAT209005A, LCA 100 V - ARDLCA219000C, LCA 100DF - ARDLCA109008A, LCA 100DF - ARDLCA109008C, LCA 100DF - ARDLCA219003A, LCA 100DF - ARDSAT209008A, LCA 100DF - ARDSAT209009A, LCA 100DF V - ARDLCA219003C, LCA 50 - ARDLCA109004A, LCA 50 - ARDLCA109004C, LCA 50 - ARDLCA209012A, LCA 50 - ARDLCA209012C, LCA 50 - ARDSAT209002A, LCA 50 MOBILE - ARDLCA309004A, LCA 50 MOBILE B - ARDLCA309005A, LCA 50 SAT - ARDSAT209003A, LCA 50 WALL 11 - ARD2LCA00140A, LCA 50DF - ARDLCA109007A, LCA 50DF - ARDLCA109007C, LCA 50DF - ARDLCA209015A, LCA 50DF - ARDLCA209015C, LCA 50DF - ARDSAT209006A, LCA 50DF - ARDSAT209007A, LCA DUO 100 - ARDLCA219001A, LCA DUO 100 V - ARDLCA219001C, LCA DUO 100+50 - ARDLCA219002A, LCA DUO 100+50 V - ARDLCA219002C, LCA DUO 100+50DF - ARDLCA219005A, LCA DUO 100+50DF V - ARDLCA219005C, LCA DUO 100DF - ARDLCA219004A, LCA DUO 100DF V - ARDLCA219004C, LCA DUO 50 - ARDLCA209013A, LCA DUO 50 - ARDLCA209013C, LCA DUO 50DF - ARDLCA209016A, LCA DUO 50DF - ARDLCA209016C, LCA100 MOBILE UPGRADE - ARDLCA506006A, LCA100 UPGRADE - ARDLCA506004A, LCA100 UPGRADE 24V - ARDLCA506005A, LCA100 WALL UPGRADE - ARDLCA506007A, LCA50 UPGRADE - ARDLCA506000A, LCA50 UPGRADE 24V - ARDLCA506001A, LCA50 UPGRADE WALL MOUNTED - ARDLCA506003A, SAT LCA 100 - ARDSAT209004C, SAT LCA 100 - ARDSAT209005C, SAT LCA 100DF - ARDSAT209008C, SAT LCA 100DF - ARDSAT209009C, SAT LCA 50 - ARDSAT209002C, SAT LCA 50 - ARDSAT209003C, SAT LCA 50DF - ARDSAT209006C, SAT LCA 50DF - ARDSAT209007C, LCA 10 MOB - ARDLCA309000A, LCA 10 MOB - ARDLCA309000C, LCA 10 MOB - ARDLCA309002A, LCA 10 MOB - ARDLCA309002C, LCA 10 MOB - ARDLCA309008C, LCA 100 MOBILE - ARDLCA309006C, LCA 100 MOBILE B - ARDLCA309007C, LCA 40 MOB - ARDLCA309001A, LCA 40 MOB - ARDLCA309001C, LCA 40 MOB - ARDLCA309003A, LCA 40 MOB - ARDLCA309003C, LCA 40 MOB - ARDLCA309009C, LCA 40GS MOBILE - ARDLCA309010A, LCA 40GS MOBILE - ARDLCA309010C, LCA 50 MOBILE - ARDLCA309004C, LCA 50 MOBILE B - ARDLCA309005C,
Why it was recalled
A potential for a light system to fall in the operating room.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
All systems affected UDI-DI: 3700712415921 3700712415853 3700712415846 3700712415877 3700712415938 3700712415860 3700712400750 3700712400613 3700712400712 3700712400729 3700712401115 3700712401122 03700712400767 3700712400620 3700712401139 3700712401146 3700712400774 3700712400637 3700712401153 3700712400736 3700712400743 3700712401160 03700712400781 3700712400644 3700712401177 3700712401184 3700712400651 3700712400668 3700712400675 3700712400682 3700712400699 03700712400705 03700712404710 03700712404697 03700712404703 03700712404727 03700712404666 03700712404673 03700712404680
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
US Nationwide. Global Distribution.
Recall record
- Recalling firm
- Getinge Usa Sales Inc
- Product type
- Devices
- Recall number
- Z-0759-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Wayne, NJ
- Recall initiated
- 2023-11-08
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-0759-2024 · Source: openFDA enforcement.