Overview of recall records associated with Maquet Medical Systems USA, including dates, categories and classifications where available.
Classification mix: Class II: 34, Class III: 1, Class I: 1.
The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or…
The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or…
The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.
Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the…
Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the…
Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of…
CARDIOHELP-i System was not properly tested to measure leakage current
Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS)…
Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential…
It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide…
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in…
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in…
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed…
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed…
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed…
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in…
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in…
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in…
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory s sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed…
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed…
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed…
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in…
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed…
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed…
This page summarizes recall records in which the official source identifies Maquet Medical Systems USA as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
