All Philips Ingenia recall
All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. It…
Why was All Philips Ingenia recalled?
In spine clinical workflows, cross reference lines may be used to determine the position of slices. In cases, where MobiView fused Images are used to show the cross reference lines, the cross reference lines may be positioned incorrectly.
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?
All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software
- Product
- All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. It…
- Recalling firm
- Philips Medical Systems, Inc.
- Quantity
- 317
- Distribution
- Worldwide Distribution-US: AL AR AZ CA CO FL GA IL IN KS KY MA MI NY OH OR PA SC TX VA VT WA OUS: Argentina Australia Austria Bangladesh Belgium Brazil Canada Chile China Colombia Denmark Ecuador Estonia Ethiopia France Germany India Indonesia Iraq Ireland Italy Japan Jordan Korea, South Malaysia Mexico Netherlands New Zealand Norway Oman Palestine Poland Russian Federation South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates United Kingdom.
- Recall date
- October 28, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)