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U.S. Department of Health and Human Services

Class 2 Device Recall Philips

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  Class 2 Device Recall Philips see related information
Date Initiated by Firm March 09, 2023
Date Posted April 12, 2023
Recall Status1 Open3, Classified
Recall Number Z-1382-2023
Recall Event ID 91915
510(K)Number K163410  K201725  
Product Classification System, x-ray, stationary - Product Code KPR
Product Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy
Model Number : 712201
Code Information UDI-DI: (01)00884838082366(21) US: Serial Numbers: 200072 200131 200132 200143 SN170053 SN180074 SN180163 SN180181 SN180182 SN190119 OUS: 200004 200005 200006 200011 200014 200015 200031 200039 200040 200041 200043 200046 200047 200048 200050 200054 200058 200059 200060 200061 200062 200063 200064 200065 200067 200068 200069 200070 200072 200073 200074 200075 200077 200078 200079 200080 200081 200082 200083 200085 200087 200089 200090 200091 200092 200093 200095 200096 200098 200099 200100 200101 200102 200103 200104 200105 200106 200107 200108 200109 200110 200112 200113 200114 200115 200116 200117 200118 200119 200120 200121 200122 200123 200124 200125 200130 200131 200132 200133 200134 200135 200138 200141 200143 200144 200146 200147 210001 210003 210007 210008 210009 210010 210011 210013 210014 210016 SN160004 SN160005 SN160006 SN160007 SN160008 SN160009 SN160011 SN160012 SN160013 SN160014 SN160015 SN160016 SN170001 SN170002 SN170003 SN170004 SN170005 SN170007 SN170008 SN170009 SN170010 SN170014 SN170015 SN170016 SN170017 SN170018 SN170019 SN170020 SN170021 SN170022 SN170023 SN170024 SN170025 SN170028 SN170029 SN170030 SN170031 SN170032 SN170033 SN170034 SN170035 SN170036 SN170037 SN170038 SN170039 SN170040 SN170041 SN170042 SN170043 SN170044 SN170045 SN170046 SN170048 SN170049 SN170050 SN170052 SN170054 SN170055 SN170056 SN170057 SN170058 SN170060 SN170061 SN170062 SN170063 SN170066 SN170067 SN170068 SN170069 SN170070 SN170071 SN170072 SN170073 SN170075 SN170076 SN170078 SN170081 SN170082 SN170083 SN170084 SN170085 SN170086 SN170087 SN170088 SN170091 SN170093 SN170097 SN170104 SN170106 SN170109 SN170111 SN170112 SN170114 SN170116 SN170118 SN170128 SN170131 SN170132 SN180006 SN180007 SN180008 SN180009 SN180010 SN180011 SN180012 SN180014 SN180015 SN180016 SN180017 SN180018 SN180019 SN180020 SN180021 SN180022 SN180023 SN180024 SN180025 SN180028 SN180029 SN180030 SN180031 SN180032 SN180033 SN180034 SN180035 SN180036 SN180038 SN180039 SN180040 SN180041 SN180043 SN180044 SN180045 SN180046 SN180047 SN180048 SN180049 SN180050 SN180051 SN180052 SN180053 SN180054 SN180055 SN180056 SN180057 SN180058 SN180059 SN180060 SN180061 SN180062 SN180063 SN180064 SN180065 SN180066 SN180067 SN180068 SN180069 SN180070 SN180071 SN180072 SN180073 SN180075 SN180076 SN180077 SN180078 SN180079 SN180080 SN180081 SN180082 SN180083 SN180085 SN180086 SN180087 SN180088 SN180089 SN180090 SN180091 SN180092 SN180093 SN180094 SN180095 SN180096 SN180097 SN180098 SN180099 SN180100 SN180101 SN180102 SN180103 SN180104 SN180105 SN180106 SN180107 SN180108 SN180112 SN180113 SN180114 SN180115 SN180116 SN180117 SN180118 SN180119 SN180120 SN180121 SN180122 SN180123 SN180124 SN180125 SN180126 SN180130 SN180131 SN180133 SN180134 SN180135 SN180136 SN180137 SN180138 SN180139 SN180140 SN180141 SN180142 SN180144 SN180145 SN180146 SN180147 SN180148 SN180150 SN180151 SN180152 SN180153 SN180154 SN180156 SN180157 SN180158 SN180159 SN180160 SN180161 SN180162 SN180164 SN180165 SN180166 SN180167 SN180168 SN180169 SN180170 SN180171 SN180172 SN180173 SN180174 SN180175 SN180176 SN180177 SN180178 SN180179 SN180180 SN180184 SN180185 SN180186 SN180187 SN180188 SN180189 SN180190 SN180191 SN180195 SN180196 SN180197 SN180198 SN180199 SN180200 SN180201 SN180202 SN180203 SN180204 SN180207 SN180208 SN180210 SN180214 SN190001 SN190002 SN190003 SN190004 SN190005 SN190006 SN190007 SN190008 SN190009 SN190013 SN190017 SN190019 SN190020 SN190022 SN190023 SN190024 SN190025 SN190026 SN190027 SN190028 SN190029 SN190030 SN190032 SN190033 SN190034 SN190035 SN190036 SN190037 SN190039 SN190040 SN190041 SN190042 SN190043 SN190044 SN190045 SN190046 SN190047 SN190048 SN190049 SN190050 SN190051 SN190052 SN190053 SN190054 SN190055 SN190056 SN190057 SN190058 SN190059 SN190060 SN190061 SN190063 SN190064 SN190066 SN190067 SN190068 SN190070 SN190071 SN190072 SN190073 SN190074 SN190075 SN190076 SN190077 SN190078 SN190079 SN190080 SN190081 SN190082 SN190083 SN190084 SN190085 SN190086 SN190087 SN190088 SN190089 SN190090 SN190093 SN190094 SN190095 SN190096 SN190097 SN190098 SN190099 SN190100 SN190101 SN190102 SN190103 SN190104 SN190105 SN190106 SN190107 SN190108 SN190109 SN190110 SN190111 SN190114 SN190118 SN190121 SN190122 SN190124 SN190125 SN190126 SN190127 SN190128 SN190129 SN190130 SN190131 SN190134 SN190136 SN190137 SN190138 SN190139 SN190140 SN190141 SN190142 SN190143 SN190144 SN190145 SN190146 SN190147 SN190148 SN190149 SN190150 SN190151 SN190154 SN190155 SN190156 SN190157 SN190158 SN190159 SN190160 SN190161 SN190163 SN190164 SN190165 SN190166 SN190167 SN190168 SN190169 SN190170 SN190174 SN190175 SN190176 SN190177 SN190178 SN190179 SN190180 SN190181 SN190183 SN190184 SN190185 SN190186 SN190187 SN190191 SN190193 SN190197 SN190198 SN190199 SN190200 SN190201 SN190202 SN190203 SN190205 SN190206 SN190207 SN190208 SN190209 SN190210 SN190211 SN190212 SN190213 SN190214 SN190216 SN190220 SN200008 SN200009 SN200010 SN200013 SN200016 SN200018 SN200020 SN200022 SN200023 SN200024 SN200025 SN200026 SN200027 SN200028 SN200029 SN200032 SN200034 SN200035 SN200037 SN200038 SN200044 SN200045 SN200049 SN200052 SN200053
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
For Additional Information Contact Philips Customer Care Solutions Center
800-722-9377
Manufacturer Reason
for Recall		 If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through normal wear and tear; as a result there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently if power to the system is interrupted, and may result in injuries to patients and users
FDA Determined
Cause 2		 Equipment maintenance
Action Philips issued Urgent Medical Device Correction Letter to US Consignees on 09-Mar-2023. Letter states reason for recall, health risk and action to take: Follow the Planned Maintenance Program in the Addendum to the Instructions for Use in Appendix A of this notice for the safe use of your system(s). " If the Ceiling Suspension is not able to be kept in its current position by itself and descends after the power to the system is off, contact your local Philips representative to perform the maintenance of the telescopic carriage. " Place this URGENT Medical Device Correction Notice with the documentation of your system(s). " Complete the enclosed Customer Reply Form and send it back to confirm that users have reviewed and understood this URGENT Medical Device Correction Notice. Philips is informing customers through this URGENT Medical Device Correction Notice and providing the Addendum to the Instructions for Use of the DigitalDiagnost C50 system. If you need additional information or support concerning this issue, please contact the Customer Care -9377).
Quantity in Commerce US: 10 units; OUS: 570 units
Distribution Nationwide including Puerto Rico and Virgin Islands Foreign: ARGENTINA Australia Austria Bosnia and Herzegovina Bulgaria China Colombia Cyprus Czech Republic Egypt France French Polynesia Germany Greece Hungary Indonesia Italy Jordan Kenya Latvia Lithuania Macedonia Malta Mexico Netherlands New Zealand Philippines Poland Portugal Puerto Rico Russian Federation Saudi Arabia Serbia Slovenia South Africa Spain Sri Lanka Switzerland Tanzania Thailand United Arab Emirates Viet Nam Yemen
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.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = Philips Healthcare (Suzhou) Co., Lit.
510(K)s with Product Code = KPR and Original Applicant = PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
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