Reported Jun 16, 2021 · Ongoing
Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- Ingenia Ambition S - Model Number781359 Diagnostic MR system
- Lot codes and dates
- REF 781359/
- UDI-DI 00884838090057 Serial numbers***Updated November 2023*** Added Serial Numbers
480004800148003480044800948005480154801748020480114802248012480144802848026480374802348043480194816048144481804811248052
480514801048038480184803948027481224804648036480474813348056481694814848154480554812848194481734813448040481554818648035481814818848198
- Amount recalled
- 156 MR systems
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Philips North America LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.