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Class 2 Device Recall Philips |
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| Date Initiated by Firm |
August 11, 2021 |
| Create Date |
September 03, 2021 |
| Recall Status1 |
Completed |
| Recall Number |
Z-2418-2021 |
| Recall Event ID |
88491 |
| 510(K)Number |
K173451
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| Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
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| Product |
Ingenia Elition 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: 781357
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| Code Information |
Serial Number Unique Device Identifier (UDI#)
Model: 781357
46029 (01)00884838088108(21)46029
46053 (01)00884838088108(21)46053
46045 (01)00884838088108(21)46045
46027 (01)00884838088108(21)46027
46042 (01)00884838088108(21)46042
46084 (01)00884838088108(21)46084
46086 (01)00884838088108(21)46086
46083 (01)00884838088108(21)46083
46030 (01)00884838088108(21)46030
46031 (01)00884838088108(21)46031
46050 (01)00884838088108(21)46050
46049 (01)00884838088108(21)46049
46052 (01)00884838088108(21)46052
46076 (01)00884838088108(21)46076
46085 (01)00884838088108(21)46085
46024 (01)00884838088108(21)46024
46044 N/A
46061 N/A
46001 (01)00884838088108(21)46001
46005 (01)00884838088108(21)46005
46011 (01)00884838088108(21)46011
46012 (01)00884838088108(21)46012
46057 (01)00884838088108(21)46057
46048 (01)00884838088108(21)46048
46021 (01)00884838088108(21)46021
46066 (01)00884838088108(21)46066
46078 (01)00884838088108(21)46078
46081 (01)00884838088108(21)46081
46060 (01)00884838088108(21)46060
46004 (01)00884838088108(21)46004
46018 (01)00884838088108(21)46018
46020 (01)00884838088108(21)46020
46013 (01)00884838088108(21)46013
46015 (01)00884838088108(21)46015
46017 (01)00884838088108(21)46017
46016 (01)00884838088108(21)46016
46023 (01)00884838088108(21)46023
46033 (01)00884838088108(21)46033
46034 (01)00884838088108(21)46034
46037 (01)00884838088108(21)46037
46025 (01)00884838088108(21)46025
46041 (01)00884838088108(21)46041
46026 (01)00884838088108(21)46026
46032 (01)00884838088108(21)46032
46036 (01)00884838088108(21)46036
46059 (01)00884838088108(21)46059
46039 (01)00884838088108(21)46039
46075 (01)00884838088108(21)46075
46046 (01)00884838088108(21)46046
46068 (01)00884838088108(21)46068
46058 (01)00884838088108(21)46058
46054 (01)00884838088108(21)46054
46082 (01)00884838088108(21)46082
46069 (01)00884838088108(21)46069
46003 (01)00884838088108(21)46003
46019 (01)00884838088108(21)46019
46008 (01)00884838088108(21)46008
46007 (01)00884838088108(21)46007
46067 (01)00884838088108(21)46067
46089 N/A
46002 (01)00884838088108(21)46002
46014 (01)00884838088108(21)46014
46065 (01)00884838088108(21)46065
46077 (01)00884838088108(21)46077
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Recalling Firm/
Manufacturer |
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
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Manufacturer 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
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FDA Determined
Cause 2 |
Device Design |
| Action |
Philips notified U.S. customers an Urgent Medical Device Correction letter on 8/11/21. Letter states reason for recall, health risk and action to take:
Philips advises that customers continue to utilize the primary motorized function for the MR system since the identified issue with the HDU does not occur in the motorized mode. If you utilize the manual function and it is not functioning properly, then you must perform table movement using the motorized function.
A Philips Field Service Engineer (FSE) will perform a HDU during the next scheduled preventive maintenance visit. If the issue is detected in the HDU, the Philips FSE will replace the necessary mechanical component(s) to resolve the issue.
If you need additional information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377) and reference FCO78100527. |
| Quantity in Commerce |
64 units |
| 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.
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| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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| 510(K) Database |
510(K)s with Product Code = LNH and Original Applicant = Philips Medical Systems Nederland B.V.
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