Z-0456-2025 Class II Ongoing
FDA device recall Z-0456-2025 was initiated by Getinge Usa Sales Inc on October 3, 2024 and is designated Class II. Reason for recall: Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand… The recall status is ongoing. Affected quantity: 342 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2024
- Initiation Date
- October 3, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 342 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bhutan, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, India, Israel, Japan, Jordan, Korea, Republic Of Kuwait, "Macedonia, The Former Yugoslav Republic Of", Malaysia, Mauritius, Mexico, Montenegro, Netherlands, New Zealand, Panama, Peru, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Viet Nam.