Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system
Summary
The FDA issued a Class II for Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for by Philips North America Llc. Reason: When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could .
Details
Source
Device Recall
External ID
Z-2416-2021
Action Date
2021-09-15
Status
Completed
Category
device
Product Description
Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781359
Lot/Code Info: Serial Number Unique Device Identifier (UDI#) 48026 (01)00884838090057(21)48026 48016 (01)00884838090057(21)48016 48053 (01)00884838090057(21)48053 48003 (01)00884838090057(21)48003 48136 (01)00884838090057(21)48136 48144 (01)00884838090057(21)48144 48020 (01)00884838090057(21)48020 48155 (01)00884838090057(21)48155 48191 (01)00884838090057(21)48191 48216 (01)00884838090057(21)48216 48124 (01)00884838090057(21)48124 48030 (01)00884838090057(21)48030 48011 (01)00884838090057(21)48011 48183 (01)00884838090057(21)48183 48186 (01)00884838090057(21)48186 48187 (01)00884838090057(21)48187 48234 (01)00884838090057(21)48234 48051 (01)00884838090057(21)48051 48000 (01)00884838090057(21)48000 48004 (01)00884838090057(21)48004 48009 (01)00884838090057(21)48009 48005 (01)00884838090057(21)48005 48019 (01)00884838090057(21)48019 48032 (01)00884838090057(21)48032 48132 (01)00884838090057(21)48132 48224 (01)00884838090057(21)48224 48223 (01)00884838090057(21)48223 48207 (01)00884838090057(21)48207 48015 (01)00884838090057(21)48015 48028 N/A 48154 N/A 48160 N/A 48134 N/A 48049 N/A 48031 N/A 48050 N/A 48131 N/A 48040 (01)00884838090057(21)48040 48039 (01)00884838090057(21)48039 48152 (01)00884838090057(21)48152 48173 (01)00884838090057(21)48173 48122 (01)00884838090057(21)48122 48022 (01)00884838090057(21)48022 48012 (01)00884838090057(21)48012 48014 (01)00884838090057(21)48014 48037 (01)00884838090057(21)48037 48036 (01)00884838090057(21)48036 48158 (01)00884838090057(21)48158 48127 (01)00884838090057(21)48127 48044 (01)00884838090057(21)48044 48184 (01)00884838090057(21)48184 48151 (01)00884838090057(21)48151 48174 (01)00884838090057(21)48174 48043 (01)00884838090057(21)48043 48046 (01)00884838090057(21)48046 48055 (01)00884838090057(21)48055 48047 (01)00884838090057(21)48047 48128 (01)00884838090057(21)48128 48129 (01)00884838090057(21)48129 48180 (01)00884838090057(21)48180 48192 (01)00884838090057(21)48192 48194 (01)00884838090057(21)48194 48153 (01)00884838090057(21)48153 48190 (01)00884838090057(21)48190 48226 (01)00884838090057(21)48226 48045 (01)00884838090057(21)48045 48033 N/A 48023 (01)00884838090057(21)48023 48181 (01)00884838090057(21)48181 48200 (01)00884838090057(21)48200 48199 (01)00884838090057(21)48199 48198 N/A 48001 (01)00884838090057(21)48001 48038 (01)00884838090057(21)48038 48167 (01)00884838090057(21)48167 48196 (01)00884838090057(21)48196 48034 (01)00884838090057(21)48034 48035 (01)00884838090057(21)48035 48172 (01)00884838090057(21)48172 48010 (01)00884838090057(21)48010 48027 N/A 48169 (01)00884838090057(21)48169 48182 (01)00884838090057(21)48182 48148 (01)00884838090057(21)48148 48188 (01)00884838090057(21)48188 48018 (01)00884838090057(21)48018 48017 (01)00884838090057(21)48017 48056 (01)00884838090057(21)48056 48112 (01)00884838090057(21)48112 48052 (01)00884838090057(21)48052 48130 (01)00884838090057(21)48130 48013 (01)00884838090057(21)48013 48162 (01)00884838090057(21)48162 48120 (01)00884838090057(21)48120 48171 (01)00884838090057(21)48171 48166 (01)00884838090057(21)48166 48179 (01)00884838090057(21)48179 48214 (01)00884838090057(21)48214 48133 (01)00884838090057(21)48133
Quantity Affected: 99 units
Reason for Recall
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-11
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 147 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-2416-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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