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During continuous post market surveillance, Draeger gathered information and market feedback indicating that there is a need to provide additional information in the instructions for use regarding the potential of the user to incorrectly position the…

During global post market surveillance activities cases have been reported that the sampling pump 6873493 shows a changing characteristic with increasing operating time, which can lead to the deactivation of the gas measurement during operation. The…

Customer complaint on over-inflation (abnormal inflation issue) occurring during the product installation, Preparation to initiate therapy or product use. In none of those events, any injury or health consequences were reported. the products in the…

Karl Ttorz Endoscopy Canada is conducting a field action for specific serial numbers of C-View endoscopes with the potential to lose image when monopolar electrocautery is activated. Recall start date: May 2, 2022

Customer complaint on over-inflation (abnormal inflation issue) occurring during the product installation, preparation to initiate therapy or product use. In none of those events, any injury or health consequences were reported. The products in the…

Field action to voluntarily remove the device due to a manufacturing error. the right nails were anodized, marked, and labelled as left nails and vice versa. Recall start date: Apr 22, 2022

Bd has confirmed through internal investigation that these products may exhibit an uncharacteristic flow profile. Our investigation confirmed there was an error during the manufacturing process. Recall start date: Apr 20, 2022

Potential non-recoverable error during Arm Cart Assembly calibration self-test leading to a delay to the surgical procedure. Recall start date: Mar 21, 2022

During manufacturing of universal twinbar 670 Qrh, the wrong center bolt was used for some twinbars. The wrong bolt does, under some circumstances, prevent a rotation of the twinbar around its center bolt. When the rotation around the bolt is inhibited,…

Maquet Cardiopulmonary Gmbh has determined during the testing of a Cardiohelp-I, that the cylindrical pin in the upper part of the transport guard can come loose. the transport guard is an accessory of the Cardiohelp-I and secures the oxygenator to the…

As a result of Shimadzu investigation, it was determined that there is an issue with the adjustment procedure documented for the calibration of the system x-ray generator. This could cause x-ray radiation dose rate to exceed regulation and/or standards…

If the Carescape Central Station v2.0 is used with an unapproved keyboard that contains a mute key, and if the mute key is pressed, the audio will be muted resulting in loss of audible alarms. this issue can result in a delay in noticing a change in…

During verification testing, a non-conformance was detected. Failure mode was uncontrolled leakage of glue from the distal tip of the Fix8 open (FX002) device. Recall start date: Feb 3, 2022

Revision D of recall: As a result of eight (8) customer complaints since revision A of this recall, a malfunction with the system controller module used in the Bio-Console 560 was identified. The malfunction is a result of the DC-DC converter and D88…

The manufacturer reported a fluid leak within the Benchmark Ultra instruments that created an electrical short on the instrument's general purpose input/output (GPIO) board's printed circuit board (PCB). The event was localized to the J1 connector of the…