| | Class 2 Device Recall PowerLED/HLED, PowerLED300 |  |
| Date Initiated by Firm | November 08, 2023 |
|---|
| Date Posted | January 19, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0763-2024 |
|---|
| Recall Event ID |
93567 |
| 510(K)Number | K070442 |
|---|
| Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
|
| Product | Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C, EPS MB1 TR - ARDINT059000A, EPS MB1 TR - ARDINT059000C, EPS MB3 - ARDINT059003A, EPS MB3 - ARDINT059003C, EPS MB3 TR - ARDINT059001A, EPS MB3 TR - ARDINT059001C, OPT MBAT - ARD568210010A, OPT MBAT - ARD568210010C, PWD30 DUAL - ARD267800310C, PWD30 DUAL - ARD267800330A, PWD30 DUAL - ARD267800330C, PWD30 DUAL - ARD267800340A, PWD30 DUAL - ARD267800340C, PWD30+DF - ARD268300170A, PWD30+DF - ARD568424110A, PWD30+DF - ARD568424110C, PWD30+DF - ARD568424114A, PWD30+DF - ARD568424114C, PWD30+DF - ARD568424511A, PWD30+DF - ARD568424511C, PWD30+DF - ARD568424512A, PWD30+DF - ARD568424512C, PWD30+DF - ARD568424513A, PWD30+DF - ARD568424513C, PWD30+DF - ARD568484114A, PWD30+DF - ARD568484114C, PWD30+DF - ARD569424110A, PWD30+DF - ARD569424110C, PWD30+DF - ARD569424114A, PWD30+DF - ARD569424114C, PWD30+DF - ARD569424511A, PWD30+DF - ARD569424511C, PWD30+DF - ARD569424512A, PWD30+DF - ARD569424512C, PWD30+DF - ARD569424513A, PWD30+DF - ARD569424513C, PWD30+DF - ARD569484114A, PWD30+DF - ARD569484114C, PWD30+DF - ARDPWD208008A, PWD30+DF - ARDPWD208008C, PWD30+DF - ARDPWD209000A, PWD30+DF - ARDPWD209000C, PWD30+DF - ARDPWD209009A, PWD30+DF - ARDPWD209009C, PWD30+DF - ARDPWD239013A, PWD30+DF - ARDPWD239013C, PWD30+DF - ARDPWD239014A, PWD30+DF - ARDPWD239014C, PWD30+DF - ARDPWD239015A, PWD30+DF - ARDPWD239015C, PWD30+DF - ARDPWD239031A, PWD30+DF - ARDPWD239031C, PWD30+DF - ARDPWD239032A, PWD30+DF - ARDPWD239032C, PWD30+DF - ARDPWD239033A, PWD30+DF - ARDPWD239033C, PWD30+SF - ARD568414110A, PWD30+SF - ARD568414110C, PWD30+SF - ARD568414114A, PWD30+SF - ARD568414114C, PWD30+SF - ARD568414511A, PWD30+SF - ARD568414511C, PWD30+SF - ARD568414512A, PWD30+SF - ARD568414512C, PWD30+SF - ARD568414513A, PWD30+SF - ARD568414513C, PWD30+SF - ARD568474114A, PWD30+SF - ARD568474114C, PWD30+SF - ARD569414110A, PWD30+SF - ARD569414110C, PWD30+SF - ARD569414114A, PWD30+SF - ARD569414114C, PWD30+SF - ARD569414511A, PWD30+SF - ARD569414511C, PWD30+SF - ARD569414512A, PWD30+SF - ARD569414512C, PWD30+SF - ARD569414513A, PWD30+SF - ARD569414513C, PWD30+SF - ARD569474114A, PWD30+SF - ARD569474114C, PWD30+SF - ARDPWD208009A, PWD30+SF - ARDPWD208009C, PWD30+SF - ARDPWD209001A, PWD30+SF - ARDPWD209001C, PWD30+SF - ARDPWD209002A, PWD30+SF - ARDPWD209002C, PWD30+SF - ARDPWD209010A, PWD30+SF - ARDPWD209010C, PWD30+SF - ARDPWD209011A, PWD30+SF - ARDPWD209011C, PWD30+SF - ARDPWD239016A, PWD30+SF - ARDPWD239016C, PWD30+SF - ARDPWD239017A, PWD30+SF - ARDPWD239017C, PWD30+SF - ARDPWD239018A, PWD30+SF - ARDPWD239018C, PWD30+SF - ARDPWD239034A, PWD30+SF - ARDPWD239034C, PWD30+SF - ARDPWD239035A, PWD30+SF - ARDPWD239035C, PWD30+SF - ARDPWD239036A, PWD30+SF - ARDPWD239036C, PWD30+SHIP - ARD268400080A, PWD30+SHIP - ARD268400080C, PWD33 S - ARD267800200A, PWD33 S - ARD267800200C, PWD33+DF - ARD568424710A, PWD33+DF - ARD568424710C, PWD33+DF - ARD568424714A, PWD33+DF - ARD568424714C, PWD33+DF - ARD568424751A, PWD33+DF - ARD568424751C, PWD33+DF - ARD568424752A, PWD33+DF - ARD568424752C, PWD33+DF - ARD568424753A, PWD33+DF - ARD568424753C, PWD33+DF - ARD568424755A, PWD33+DF - ARD568424755C, PWD33+DF - ARD568424758A, PWD33+DF - ARD568424758C, PWD33+DF - ARD569424710A, PWD33+DF - ARD569424710C, PWD33+DF - ARD569424714A, PWD33+DF - ARD569424714C, PWD33+DF - ARD569424751A, PWD33+DF - ARD569424751C, PWD33+DF - ARD569424752A, PWD33+DF - ARD569424752C, PWD33+DF - ARD569424753A, PWD33+DF - ARD569424753C, PWD33+DF - ARD569424755A, PWD33+DF - ARD569424755C, PWD33+DF - ARD569424758A, PWD33+DF - ARD569424758C, PWD33+SF - ARD568414710A, PWD33+SF - ARD568414710C, PWD33+SF - ARD568414714A, PWD33+SF - ARD568414714C, PWD33+SF - ARD568414751A, PWD33+SF - ARD568414751C, PWD33+SF - ARD568414752A, PWD33+SF - ARD568414752C, PWD33+SF - ARD568414753A, PWD33+SF - ARD568414753C, PWD33+SF - ARD568414755A, PWD33+SF - ARD568414755C, PWD33+SF - ARD568414758A, PWD33+SF - ARD5684147 |
|---|
| Code Information |
All systems affected.
UDI-DI:
3700712405847
3700712406134
03700712405977
3700712403133
03700712403140
03700712402259
03700712402266
03700712402273
03700712404277
03700712403232
03700712403454
03700712402471
03700712402488
03700712402495
3700712403010
03700712403027
03700712403744
03700712403751
03700712403768
3700712403478
03700712403249
03700712403256
03700712403263
03700712402501
03700712402518
03700712402525
¿3700712406103
03700712403157
03700712403164
03700712403942
03700712403959
03700712403966
03700712403034
03700712403041
03700712403775
03700712403782
03700712403799
03700712403805
03700712405779
03700712403065
03700712403072
03700712402136
03700712402143
03700712402150
03700712402570
03700712401856
03700712401863
03700712401870
03700712402655
03700712403461
03700712403393
03700712406011
03700712402778
03700712402426
03700712402433
03700712402440
03700712402044
03700712402051
03700712402068
03700712402945
03700712402952
03700712403539
03700712403546
03700712403553
03700712402549
03700712402662
03700712403270
03700712403287
03700712411947
03700712402785
03700712402792
03700712402358
03700712402457
03700712402464
03700712404376
03700712401979
03700712402075
03700712402082
03700712403089
03700712403096
03700712402167
03700712402174
03700712403836
03700712403843
03700712402587
03700712401887
03700712401894
03700712402693
03700712403386
03700712402853
03700712404413
03700712402969
03700712402976
03700712403560
03700712403577
03700712403584
03700712403591
03700712402556
03700712402686
03700712403379
03700712402839
03700712402747
03700712403058
03700712402112
03700712402129
03700712403812
03700712403829
03700712402563
03700712401832
03700712401849
03700712414153
03700712403362
03700712404314
03700712402860
03700712402938
03700712403492
03700712403508
03700712403515
03700712403522
03700712402532
03700712402709
03700712403355
03700712404345
03700712402846
03700712404390
03700712402877
03700712404284
03700712405762
03700712403119
03700712402204
03700712402211
03700712402228
03700712403218
03700712404192
03700712404208
03700712402327
03700712402631
03700712401924
03700712401931
03700712401948
03700712403294
03700712403409
03700712403485
03700712405823
03700712406028
03700712405830
03700712402808
03700712402907
03700712402365
03700712402372
03700712402389
03700712401986
03700712401993
03700712402006
03700712402990
03700712403690
03700712403706
03700712403713
03700712403188
03700712404062
03700712404079
03700712404086
03700712402600
03700712402679
03700712403300
03700712403317
03700712403324
03700712403430
03700712411954
03700712402815
03700712402822
03700712402396
03700712402402
03700712402419
03700712404383
03700712402013
03700712402020
03700712402037
03700712403126
03700712402235
03700712402242
03700712403928
03700712403935
03700712403225
03700712402334
03700712402341
03700712404215
03700712404222
03700712402648
03700712401955
03700712401962
03700712402914
03700712403003
03700712402099
03700712402105
03700712403720
03700712403737
03700712403195
03700712402280
03700712402297
03700712404093
03700712404109
03700712402617
03700712402723
03700712402716
03700712403416
03700712403423
03700712402754
03700712402921
03700712403102
03700712402181
03700712402198
03700712403850
03700712403867
03700712403201
03700712402303
03700712402310
03700712404123
03700712404130
03700712402624
03700712401900
03700712401917
03700712413385
03700712403348
03700712404307
03700712404352
03700712402891
03700712404406
03700712402983
03700712403607
03700712403614
03700712403621
03700712403638
03700712403171
03700712403973
03700712403980
03700712403997
03700712404000
03700712402594
03700712403331
03700712404338
03700712402884
03700712402730
03700712403447
03700712402761
03700712403874
03700712403881
03700712403898
03700712403904
03700712403911
03700712404147
03700712404154
03700712404161
03700712404178
03700712404185
03700712404239
03700712404246
03700712404253
03700712404260
03700712404291
03700712403645
03700712403652
03700712403669
03700712403676
03700712403683
03700712404017
03700712404024
03700712404031
03700712404048
03700712404055
03700712404116
03700712404321
03700712404369
03700712404451
03700712404499
03700712404444
03700712404482
03700712404437
03700712404475
03700712404420
03700712404468
03700712404529
03700712404536
03700712404567
03700712404574
03700712404505
03700712404512
03700712404543
03700712404550
03700712413392
03700712401795
03700712401801
03700712401818
03700712401825
|
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 = FSY
|
|---|
|
|
|
