Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can
Summary
The FDA issued a Class II for Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for us 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-2414-2021
Action Date
2021-09-15
Status
Completed
Category
device
Product Description
Ingenia 1.5T CX-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: 781261 781262
Lot/Code Info: Model: 781261 Serial Number Unique Device Identifier (UDI#) 77008 77000 77004 77007 77003 77001 77002 77018 77016 77019 77010 77014 Model:781262 77131 (01)00884838068445(21)77131 77031 N/A 77046 N/A 77070 N/A 77124 (01)00884838068445(21)77124 77144 (01)00884838068445(21)77144 77172 (01)00884838068445(21)77172 77074 (01)00884838068445(21)77074 77058 N/A 77114 N/A 77127 (01)00884838068445(21)77127 77160 (01)00884838068445(21)77160 77159 (01)00884838068445(21)77159 77182 (01)00884838068445(21)77182 77180 (01)00884838068445(21)77180 77171 (01)00884838068445(21)77171 77179 (01)00884838068445(21)77179 77048 N/A 77040 N/A 77034 N/A 77039 N/A 77035 N/A 77092 N/A 77140 (01)00884838068445(21)77140 77177 (01)00884838068445(21)77177 77181 (01)00884838068445(21)77181 77178 (01)00884838068445(21)77178 77041 N/A 77103 N/A 77193 (01)00884838068445(21)77193 77203 (01)00884838068445(21)77203 77134 (01)00884838068445(21)77134 77047 N/A 77051 N/A 77050 N/A 77060 N/A 77194 (01)00884838068445(21)77194 77111 N/A 77119 (01)00884838068445(21)77119 77167 (01)00884838068445(21)77167 77183 (01)00884838068445(21)77183 77185 (01)00884838068445(21)77185 77187 (01)00884838068445(21)77187 77188 (01)00884838068445(21)77188 77198 (01)00884838068445(21)77198 77195 (01)00884838068445(21)77195 77196 (01)00884838068445(21)77196 77199 N/A 77202 N/A 77037 N/A 77057 N/A 77072 N/A 77075 N/A 77084 N/A 77085 N/A 77078 N/A 77086 N/A 77101 N/A 77110 (01)00884838068445(21)77110 77038 (01)00884838068445(21)77038 77157 (01)00884838068445(21)77157 77156 (01)00884838068445(21)77156 77056 N/A 77052 N/A 77054 N/A 77053 N/A 77055 N/A 77064 N/A 77065 N/A 77067 N/A 77066 N/A 77068 N/A 77069 N/A 77105 N/A 77126 (01)00884838068445(21)77126 77125 (01)00884838068445(21)77125 77137 (01)00884838068445(21)77137 77139 (01)00884838068445(21)77139 77136 (01)00884838068445(21)77136 77135 (01)00884838068445(21)77135 77138 (01)00884838068445(21)77138 77148 (01)00884838068445(21)77148 77141 (01)00884838068445(21)77141 77030 N/A 77033 N/A 77036 N/A 77042 N/A 77044 N/A 77043 N/A 77032 N/A 77049 N/A 77061 N/A 77059 N/A 77071 N/A 77090 N/A 77088 N/A 77093 N/A 77091 N/A 77087 N/A 77097 N/A 77083 N/A 77106 N/A 77112 N/A 77107 (01)00884838068445(21)77107 77115 N/A 77100 (01)00884838068445(21)77100 77118 (01)00884838068445(21)77118 77121 (01)00884838068445(21)77121 77129 (01)00884838068445(21)77129 77120 (01)00884838068445(21)77120 77128 (01)00884838068445(21)77128 77151 (01)00884838068445(21)77151 77143 (01)00884838068445(21)77143 77158 (01)00884838068445(21)77158 77162 (01)00884838068445(21)77162 77161 (01)00884838068445(21)77161 77155 (01)00884838068445(21)77155 77190 (01)00884838068445(21)77190 77191 (01)00884838068445(21)77191 77150 (01)00884838068445(21)77150 77081 N/A 77117 (01)00884838068445(21)77117 77123 (01)00884838068445(21)77123 77166 (01)00884838068445(21)77166 77045 N/A 77063 N/A 77109 N/A 77201 (01)00884838068445(21)77201 77113 N/A 77147 (01)00884838068445(21)77147 77122 (01)00884838068445(21)77122 77154 (01)00884838068445(21)77154 77169 (01)00884838068445(21)77169 77168 (01)00884838068445(21)77168 77130 (01)00884838068445(21)77130 77094 N/A 77062 N/A
Quantity Affected: 12 units, 137 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-2414-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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