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
This recall has been terminated (originally issued March 25, 2019).
- Recall Initiated
- March 25, 2019
- Terminated
- June 4, 2020
- Recall Number
- Z-1240-2019
- Quantity
- 4 units
- Official Source
- View on FDA website ↗
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
US Distribution to state of: FL and Internationally to: Switzerland and Germany.
Lot / Code Info
US Serial Number: 47004 OUS Serial Numbers: 47001, 47002, 48000
Root Cause
Device Design
Action Taken
Philips issued an "URGENT - Medical Device Correction" letter on 3/25/2019 via certified mail to its customers. Philips Key Markets are responsible for distributing the letters outside of the U.S. Letter identifies the problem, health risk and actions to be taken. The customers were informed that no action from the customer or user of the device is required, as the Magnet Energization Device (MED) is located in a cabinet in the Technical Room, with the output terminals of the MED located behind locked protective covers. Only qualified servicing personnel have access to this. the Magnet PHILIPS Energization Device (MED) will be replaced by a new version, which does not have this problem. If you need any further information or support concerning this issue, please INFORMATION AND contact your local Philips representative or call the Quality Specialist DI BG Q&R Post Market Surveilla at 678-2960248 or email to: Etseguenet.Kinde@philips.com.