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GETINGE US SALES Recalls
12 recalls on record · April 4, 2018 to December 18, 2019 · Medical Devices
Recalls by year
18
19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 18, 2019Medical DevicesFDA
GETINGE US SALES LLC recalls Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile
Hazard: Sterile barrier system may be compromised
October 2, 2019Medical DevicesFDA
GETINGE US SALES LLC recalls The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with hig
Hazard: Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft product with the diameter size of 16 x 9 mm is likely incorrectly packed inside of the carton which was labeled to contain a HEMASHIELD PLATINUM Woven Double Velour Vascular Graft product with the diameter size of 16 x 8 mm ((REF: M00202166168P0, Lot: 18K31, SN: 1190443415, size 16 x 8 mm).
September 11, 2019Medical DevicesFDA
GETINGE US SALES LLC recalls Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.
Hazard: Reversed expiration and manufacturing date on the label
July 31, 2019Medical DevicesFDA
GETINGE US SALES LLC recalls PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring Syste
Hazard: The monitor displays an error message . The error message states "internal error restart or service".
May 1, 2019Medical DevicesFDA
GETINGE US SALES LLC recalls Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usag
Hazard: Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes
March 13, 2019Medical DevicesFDA
GETINGE US SALES LLC recalls Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Number ARD2SAT00130A Product Usage: This p
Hazard: The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain conditions while using the flat screen monitor holder with voltage of 100-220V.
March 13, 2019Medical DevicesFDA
GETINGE US SALES LLC recalls Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration Part Number ARD268400150A Product Usag
Hazard: The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain conditions while using the flat screen monitor holder with voltage of 100-220V.
March 13, 2019Medical DevicesFDA
GETINGE US SALES LLC recalls Maquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE, Configuration Part Number ARD268400140A Product Usage: T
Hazard: The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain conditions while using the flat screen monitor holder with voltage of 100-220V.
March 13, 2019Medical DevicesFDA
GETINGE US SALES LLC recalls Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product Usage: This product i
Hazard: The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain conditions while using the flat screen monitor holder with voltage of 100-220V.
May 30, 2018Medical DevicesFDA
GETINGE US SALES LLC recalls ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the pa
Hazard: Getinge has received complaints concerning the X TEN Surgical Lights whose spring arms have broken, causing light heads to separate from the assembly. The issue relates to cracking of the spring arms at the weld seams that has the potential to develop into breaks with heavy use and aging of the equipment.
April 18, 2018Medical DevicesFDA
GETINGE US SALES LLC recalls VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD56881191
Hazard: The manufacturer received complaints indicating that the device's central handle holder detaches easily from the handle holder ring on the light head during clinical use. In the event of such detachment, particles from the handle holder ring could fall into the sterile field during a procedure.
April 4, 2018Medical DevicesFDA
GETINGE US SALES LLC recalls HEMASHIELD Knitted Double Velour Cardiovascular Fabric
Hazard: A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).