Z-1512-2024 Class I Ongoing
FDA device recall Z-1512-2024 was initiated by Draeger Medical, Inc. on Mar 20, 2024 and is designated Class I. Reason for recall: Unexpected shutdown while operating on battery power. The recall status is ongoing. Affected quantity: 16,841 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 24, 2024
- Initiation Date
- Mar 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,841 units
Product Description
Reason for Recall
Distribution Pattern
Domestic: Nationwide Distribution; Foreign: Angola, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Botswana, Brazil, Brunei Dar-se- S, Bulgaria, Canada, Chili, China, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, French Guiana, Georgia, Germany, Gibraltar, Greece, Guadeloupe, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Liechtenstein, Lithuania, Malaysia, Maldives, Mauritius, Mayotte, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, Uganda, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Vietnam.