| | Class 2 Device Recall Lucea10/40, Lucea50/100 |  |
| Date Initiated by Firm | November 08, 2023 |
|---|
| Date Posted | January 19, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0759-2024 |
|---|
| Recall Event ID |
93567 |
| 510(K)Number | K113679 |
|---|
| Product Classification |
Lamp, surgical - Product Code FTD
|
| Product | 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, |
|---|
| 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 |
Recalling Firm/
Manufacturer |
Getinge Usa Sales Inc
1 Geoffrey Way
Wayne NJ 07470-2035
|
| For Additional Information Contact | Jessica Minaya
973-709-7634 |
|---|
Manufacturer Reason
for Recall | A potential for a light system to fall in the operating room. |
|---|
FDA Determined
Cause 2 | 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 other replacements:
Regarding:
- the fixing of the light systems: suspensions fixing screws, adapter fixing screws, bushing fixing screws
- the brake screws
- the safety segments
- the batteries, a dedicated instruction to illustrate and facilitate understanding of what to replace and what to order for replacement has been issued.
The instruction is available on a dedicated space on the web portal
https://www.getinge.com/int/campaigns/maintenance-and-service-on-or-light-system/,
and provided upon request by emailing MSA808092.sw@getinge.com
Should you have questions or require additional information, please do not hesitate to contact Maquet SAS/Getinge or your local representative.
Please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE
FORM (page 7) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to
or-lights2023.qrc@getinge.com or by faxing the form to (866) 350-0897.
If you are a distributor who has shipped any affected products to customers, please
forward this document to their attention for appropriate action.
Actions to be taken by Maquet SAS / Getinge:
As the majority of customers may not have regular contact with Getinge services or authorized Getinge representatives and therefore may not be aware of current maintenance recommendations, Maquet SAS/Getinge is providin |
|---|
| Quantity in Commerce | 236793 units in total |
|---|
| Distribution | US Nationwide. Global Distribution. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = FTD
|
|---|
|
|
|
