Medical device recalls

There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.

This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatures. All EKOS CU 4.0 consoles containing the old RF board design will be replaced with the newly designed CU 4.0 consoles.

It has been determined that the software distributed with the retinal camera may delete patient information. Specifically, if multiple IDs are delated at the same time, their is a potential for all patient information to be deleted. This could result in delay of treatment.

Due to complaints received associated with cracked/split test tube caps.

Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.

The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.

The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

RevMedX Trauma Dressing is being recalled due to package seal integrity.

Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guaranteed in that the safety function of the board would be insufficient resulting in an increased leakage of current and potentially cause electrical shocks to the user.

Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guaranteed in that the safety function of the board would be insufficient resulting in an increased leakage of current and potentially cause electrical shocks to the user.

A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.

Product does not meet internal testing criterion; use of the product may result in a potential false positive test result and may lead to patients undergoing unnecessary follow-up diagnostic procedure, i.e., colonoscopy or sigmoidoscopy

Two issues were found with the treatment plan report: 1) There may be incorrect information for the percent of a region of interest with a clinical goal that is outside the dose grid; and 2) For RayStation and RayPlan 9B and 10A, 6D couch angles may be incorrect.

BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2" Lot No. 9128897. The possibility of infection may be present if the blood is not noticed prior to use by the clinician.