Z-0547-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2024
- Initiation Date
- November 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,231 units
Product Description
ST SENSE Breast Coil
Reason for Recall
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Distribution Pattern
US Nationwide distribution.
Code Information
REF: 453530054571; UDI-DI: 00884838066625; Serial No. 36577, 36597, 36664, 36706, 36540, 36604, 36590, 36670, 36671, 36704, 36710, 36712, 36524, 36555, 36519, 36521, 36570, 36573, 36582, 36580, 36581, 36603, 36619, 36663, 36680, 36711, 36548, 36576, 36589, 36606, 36523, 36567, 36572, 36601, 36639, 36661, 36536, 36588, 36635, 36631, 36668, 36613, 36677, 36530, 36556, 36661, 36575, 36592, 36632, 36657, 36669, 36602, 36674, 36703, 36534, 36551, 36541, 36549, 36547, 36525, 36526, 36528, 36574, 36571, 36595, 36614, 36605, 36600, 36636, 36634, 36662, 36641.