Z-1884-2024 Class II Ongoing
FDA device recall Z-1884-2024 was initiated by FUJIFILM Healthcare Americas Corporation on April 11, 2024 and is designated Class II. Reason for recall: AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable). The recall status is ongoing. Affected quantity: 418 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2024
- Initiation Date
- April 11, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 418 units
Product Description
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
Reason for Recall
AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI: (01) 04580292771704 Noblus Ultrasound Imaging System AC Adapter Serial Number Before K17160001 (Excluding K17160001)