Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectr
Summary
The FDA issued a Class II for Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional im by Philips North America Llc. Reason: Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other.
Details
Source
Device Recall
External ID
Z-3197-2024
Action Date
2024-10-02
Status
Ongoing
Category
device
Product Description
Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782108 2) 781359 3) 782133
Lot/Code Info: Model UDI-DI: 782108 (01)00884838098343(21); 781359 (01)00884838090057(21). 782133 N/A Serial Numbers: 27506 27508 27509 27512 27514 27515 27516 27517 27518 27519 27520 27523 27524 27525 27526 27528 27531 48146 48164 48550 48556 48588 48589 48608 48612 48627 48648 48661 48662 48663 48664 48665 48666 48667 48669 48672 48679 48686 48688 48694 48696 48697 48698 48699 48700 48707 48708 48710 48714 48715 48721 48725 48726 48728 48729 48738 48744 48749 48754 48800 48804 48810 48813 48833
Quantity Affected: 64 units
Reason for Recall
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Iceland, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Maldives, Mauritius, Mexico, Morocco, Netherlands, Pakistan, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Uzbekistan, Vietnam.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-03
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 244 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips North America Llc has 302 FDA actions in our database, including 302 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America Llc have FDA actions?
Philips North America Llc has 302 FDA actions in our database, including 302 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3197-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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