Z-1240-2019 Class II Terminated
FDA device recall Z-1240-2019 was initiated by Philips Medical Systems Nederlands on March 25, 2019 and is designated Class II. Reason for recall: Magnet Energization Device (MED) can have a residual voltage on output terminal, may cause electrical shocks to personnel servicing the MED, MDD or connected cabling. The recall status is terminated (terminated June 4, 2020). Affected quantity: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2019
- Initiation Date
- March 25, 2019
- Termination Date
- June 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the magnet. MED is abbreviation for Magnet Energize Device
Reason for Recall
Magnet Energization Device (MED) can have a residual voltage on output terminal, may cause electrical shocks to personnel servicing the MED, MDD or connected cabling.
Distribution Pattern
US Distribution to state of: FL and Internationally to: Switzerland and Germany.
Code Information
US Serial Number: 47004 OUS Serial Numbers: 47001, 47002, 48000