Z-0595-2024 Class III Ongoing
FDA device recall Z-0595-2024 was initiated by Maquet Medical Systems USA on November 14, 2023 and is designated Class III. Reason for recall: CARDIOHELP-i System was not properly tested to measure leakage current The recall status is ongoing. Affected quantity: 1594 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 27, 2023
- Initiation Date
- November 14, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1594 units
Product Description
Reason for Recall
Distribution Pattern
Nationwide-WW Distribution to Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iran, Islamic Republic Of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic Of Kuwait, Lebanon, Luxembourg, Macao, Maldives, Martinique, Mayotte, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom,Vietnam, Yemen