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Maquet Spring Arms (2017-10-03)
- Starting date:
- October 3, 2017
- Posting date:
- October 27, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-64940
Affected products
- Spring Arm for HLX 2000
- Spring Arm for 3000
- XTEN Spring Arm
- XTEN Video Spring Arm
- Spring Arm for 3004 TV
Reason
Fissured or broken weld seams continue to be reported from the field for HLX 2004-5 DF, HLX 3004-5DF and XTEN DF. The spring arms that are still in use are now more than 10 years old. This new field action is launched to replace all remaining spring arms in combination with HLX 2004-5 DF, HLX 3004-5 DF and XTEN DF.
Affected products
-
Spring Arm for HLX 2000
Lot or serial number
up to SN 4306038616
Model or catalog number
ARD569002999
Companies
- Manufacturer
-
Maquet S.A.
Avenue de la Pomme De Pin, Parc De Limere
Ardon, Orleans
45074
FRANCE
B. Spring Arm for 3000
Lot or serial number
up to SN 35060032600
Model or catalog number
ARD567910901
Companies
- Manufacturer
-
Maquet S.A.
Avenue de la Pomme De Pin, Parc De Limere
Ardon, Orleans
45074
FRANCE
C. XTEN Spring Arm
Lot or serial number
up to SN 36060033055
Model or catalog number
ARD567801093
Companies
- Manufacturer
-
Maquet S.A.
Avenue de la Pomme De Pin, Parc De Limere
Ardon, Orleans
45074
FRANCE
D. XTEN Video Spring Arm
Lot or serial number
up to SN 45060039322
Model or catalog number
ARD567801094
Companies
- Manufacturer
-
Maquet S.A.
Avenue de la Pomme De Pin, Parc De Limere
Ardon, Orleans
45074
FRANCE
E. Spring Arm for 3004 TV
Lot or serial number
up to SN 44060038859
Model or catalog number
ARD567910910
Companies
- Manufacturer
-
Maquet S.A.
Avenue de la Pomme De Pin, Parc De Limere
Ardon, Orleans
45074
FRANCE