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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-2416-2021 |
| Recall Event ID |
88491 |
| 510(K)Number |
K181479
|
| Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
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| Product |
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
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| Code Information |
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
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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
|
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 |
99 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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