Philips North America Llc: ST SENSE Breast Coil

Hazard

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Details from the source

Reason for recall: Potential safety issue where a patient may be harmed while preparing for or during a scan. Distribution: US Nationwide distribution. Quantity: 5,231 units Lot/code info: 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.

UPC codes

453530054571, 00884838066625

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.