WOM World Of Medicine AG

2 recalls •

• Categories: Other Medical Devices, Diagnostic Equipment

WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-01

Class I - Dangerous

Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery

May 24, 2024 Other Medical Devices Nationwide View Details →

Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P

Class I - Dangerous

The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid overload

Jul 17, 2023 Diagnostic Equipment Nationwide View Details →

Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000

Class I - Dangerous

When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reaching the soft tissue circulatory system.

Jun 18, 2021 Other Medical Devices Nationwide View Details →

Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.

Class I - Dangerous

The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.

Aug 14, 2019 Diagnostic Equipment Nationwide View Details →

PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vessel Harvest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using C02 gas during trans anal minimal invasive surgery.

Class I - Dangerous

It is possible that the packaging of the product can be damaged by the prongs on the tube set.

Oct 22, 2018 Diagnostic Equipment View Details →