| | Class 2 Device Recall Philips |  |
| Date Initiated by Firm | August 11, 2021 |
|---|
| Create Date | September 03, 2021 |
|---|
| Recall Status1 |
Completed |
| Recall Number | Z-2414-2021 |
|---|
| Recall Event ID |
88491 |
| 510(K)Number | K162931 |
|---|
| Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
| Product | 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 |
|---|
| Code Information |
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
|
Recalling Firm/
Manufacturer |
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
|
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 | 12 units, 137 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.
|
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
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.
|
| 510(K) Database | 510(K)s with Product Code = LNH
|
|---|
|
|
|
