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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

37,779 Total Recalls

Proteus 235-Proton Therapy System

Ion Beam Applications S.A.

Class I - Dangerous

if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position

May 26, 2021 Other Medical Devices View Details →

Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.

Maquet Medical Systems USA

Class I - Dangerous

There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.

Jul 14, 2021 Other Medical Devices View Details →

Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 100 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/15, Length 150 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/20, Length 200 mm, Diameter 18 G (1.25 mm); Article no. BIM 16/10, Length 100 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/15, Length 150 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/20, Length 200 mm, Diameter 16 G (1.6 mm); Article no. BIM 14/10, Length 100 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/15, Length 150 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/20, Length 200 mm, Diameter 14 G (2.1 mm) *NOT DISTRIBUTED WITHIN THE US

INNOVATIVE TOMOGRAPHY PRODUCT GMBH

Class I - Dangerous

Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized

Apr 21, 2021 Diagnostic Equipment Nationwide View Details →

Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM 22/05, Length 50 mm, diameter 22G/0,7 mm; Article no. KIM 22/07,Length 75 mm, diameter 22 G (0.7 mm); Article no. KIM 22/10, Length 100 mm, diameter 22 G (0.7 mm); Article no. KIM 20/15, Length 150 mm, diameter 20 G (0.9 mm); Article no. KIM 18/10, Length 100 mm, diameter 18 G (1.25 mm); Article no. KIM 18/10T, Length 100 mm, diameter 18 G (1.25 mm); Article no. KIM 18/15, Length 150 mm, diameter 18 G (1.25 mm); Article no. KIM 18/15T, Length 150 mm, diameter 18 G (1.25 mm); Article No. KIM 18/20, Length 200 mm, diameter 18G/1.27mm, Article no. KIM 13/04T, Length 44 mm, diameter 13 G (2.40 mm); Article no. KIM 13/09T, Length 94 mm , diameter 13 G (2.40 mm); Article no. KIM 13/14T, Length 144 mm, diameter 13 G (2.40 mm); Article no. KIM 15/04T, Length 44 mm, diameter 15 G (1.95 mm); Article no. KIM 15/09T, Length 94 mm, diameter 15 G (1.95 mm); Article no. KIM 15/14T, Length 144 mm, diameter 15 G (1.95 mm); Article no. KIM 16/04T,Length 44 mm, diameter 16 G (1.60 mm); Article no. KIM 16/09T, Length 94 mm, diameter 16 G (1.60 mm); Article no. KIM 16/14T, Length 144 mm, diameter 16 G (1.60 mm); Article no. KIM 14/20T, Length 200 mm, Diameter 14 G (2.1 mm)

INNOVATIVE TOMOGRAPHY PRODUCT GMBH

Class I - Dangerous

Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized

Apr 21, 2021 Diagnostic Equipment Nationwide View Details →