Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Philips

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Philipssee related information
Date Initiated by FirmMarch 09, 2023
Date PostedApril 12, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1383-2023
Recall Event ID 91915
510(K)NumberK163410 K201725 
Product Classification System, x-ray, stationary - Product Code KPR
ProductDigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
Code Information UDI-DI: (01)00884838095199(21)210159 US: Serial Numbers: 210034 210049 210097 210182 210187 210245 220002 220006 220009 220020 OUS: 200001 200002 200005 200006 200007 200009 200010 200011 200012 200013 200014 200015 200017 200018 200019 200022 200023 200024 200026 200027 200028 200029 200030 200031 200032 200033 200034 200035 200036 200037 200040 200041 200042 200044 200045 200046 200047 200048 200049 200050 200051 200052 200053 200055 200056 200058 200063 200064 200067 200068 210001 210002 210003 210004 210005 210006 210007 210008 210009 210010 210011 210012 210016 210017 210018 210019 210020 210021 210022 210023 210024 210025 210026 210027 210028 210029 210030 210031 210032 210033 210035 210036 210037 210038 210039 210056 210057 210058 210059 210060 210061 210063 210064 210065 210066 210067 210068 210070 210071 210072 210073 210074 210075 210076 210077 210078 210079 210081 210082 210083 210086 210087 210089 210090 210092 210096 210098 210100 210101 210103 210104 210105 210106 210108 210109 210111 210112 210118 210119 210121 210128 210129 210132 210134 210135 210136 210138 210139 210140 210141 210145 210146 210148 210149 210150 210151 210152 210154 210155 210156 210157 210158 210159 210167 210168 210169 210171 210172 210173 210174 210175 210179 210180 210181 210186 210189 210191 210192 210194 210196 210197 210198 210206 210208 210210 210211 210213 210214 210215 210216 210219 210220 210221 210222 210223 210224 210225 210226 210227 210228 210229 210230 210231 210235 210236 210237 210240 210241 210246 220001 220003 220004 220005 220015 220017 220018 220019 220021 220023 220024 220025 220026 220027 220033 220034 220036 220037 220038 220039 220040 220041 220042 220043 220044 220045 220046 220047 220048 220049 220050 220051 220052 220053 220054 220055 220056 220057 220058 220059 220061 220062 220064 220066 220067 220068 220069 220070 220073 220074 220075 220076 220078 220095 220096 220097 220099 220100 220101 220102 220103 220104 220105 220106 220107 220108 220113 220114 220115 220116 220117 220122 220123 220126 220127 220128 220129 220130 220131 220132 220133 220134 220137 220139
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
For Additional Information ContactPhilips 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
ActionPhilips 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 Commerce10 units US; 283 units OUS
DistributionNationwide 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 CycleTPLC 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) Database510(K)s with Product Code = KPR
510(K)s with Product Code = KPR
-
-