Recall Z-0768-2024 ยท FSY Light, Surgical, Ceiling Mounted
Getinge Usa Sales Inc
Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211C, 4001 SAD/DF - ARD567221241C, 4001 SAD/SF - ARD567221141C, 4001 SAI/DF - ARD567220111C, 4001K S/DF - ARD567211213C, 4003 - ARD567215111C, 4401 S/DF - ARD567212211C, 4401 SAD/DF - ARD567223211
| Date | Jan 19, 2024 (initiated Nov 8, 2023) |
| Status | Open, Classified |
| Reason | A potential for a light system to fall in the operating room. |
| Root cause | Equipment maintenance |
| Action | An URGENT MEDICAL DEVICE CORRECTION letter dated 11/8/23 was sent to customers. Actions to be taken by the customer: Our records indicate that you have been identified as having purchased at least one model of one of these product ranges. Please identify your affected units using the referenced devices on page 1 and follow the instructions below. Please distribute this notice and forward the link below to access manuals to anyone within your organization who may need to use the manuals, and especially to your service or service provider who performs your maintenance. Light system fixing and |
| Quantity | 236793 units in total |
| Distribution | US Nationwide. Global Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932451 | HANAULUX 2005 SURGICAL LIGHT Heraeus Instruments GmbH, Nov 12, 1993 |