FDAClass IIMay 8, 2019

Ingenia Ambition S recall

Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a…

Why was Ingenia Ambition S recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

US Serial Number: 47004 OUS Serial Numbers: 47001, 47002, 48000

Product
Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a…
Recalling firm
Philips Medical Systems Nederlands
Quantity
4 units
Distribution
US Distribution to state of: FL and Internationally to: Switzerland and Germany.
Recall date
May 8, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls