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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 Philipssee related information
Date Initiated by FirmNovember 19, 2021
Create DateDecember 22, 2021
Recall Status1 Terminated 3 on February 07, 2024
Recall NumberZ-0416-2022
Recall Event ID 89203
510(K)NumberK130842 K141979 K161563 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductPhilips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, 722028.
Code Information US Serial Number/UDI: 1 (01)00884838054202(21)1; 527 (01)00884838059054(21)527; 408 (01)00884838054202(21)408; 306 (01)00884838054202(21)306; 61 (01)00884838059030(21)61 OUS: Model Product S/N UDI: 722006 Allura Xper FD20 1997 (01)00884838059191(10)1997; 722010 Allura Xper FD10 1177 (01)00884838059030(21)1177; 722010 Allura Xper FD10 1178 (01)00884838059030(21)1178; 722013 Allura Xper FD20 Biplane 544;; 722010 Allura Xper FD10 514 (01)00884838059030(21)514; 722013 Allura Xper FD20 Biplane 271; 722025 Allura Xper FD20 Biplane OR Table 6; 722005 Allura Xper FD10/10 519; 722008 Allura Xper FD20 Biplane 531; 722012 Allura Xper FD20 1901 (01)00884838059054(21)1901; 722012 Allura Xper FD20 2505 (01)00884838059054(21)2505; 722013 Allura Xper FD20 Biplane 137; 722026 Allura Xper FD10 439 (01)00884838054189(21)439; 722134 Field ext. Xper vascular systems R7.6 98736; 722027 Allura Xper FD10/10 172 (01)00884838054196(21)172;
Recalling Firm/
Manufacturer
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
Manufacturer Reason
for Recall
Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling Suspension structure and fall down, may lead to patient, user or service engineer harm that may require medical intervention.
FDA Determined
Cause 2
Other
ActionPhilips issued Medical Device Correction letter to US consignees on 19-Nov-2021. Letters outside of the U.S.A. will be distributed through the Philips Markets Organization. Letter states reason for recall, health risk and action to take: Move the MCS with a 7th or 8th monitor only before or after a procedure. " Do not position the MCS above the patient/sterile field during the procedure. " Place this Field Safety Notice with the system documentation until your system has been fixed. " Circulate this notice to all users of this device so they are aware of the product issues. " Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Field Safety Notice. A Philips representative will secure the set of screws of all affected systems. You will be contacted by your local Philips representative to schedule the service. If you need any further information, please contact your local Philips representative (reference to FC072200488).
Quantity in CommerceUSA: 5 systems R.O.W.: 15 systems
DistributionWorldwide distribution - US Nationwide distribution in the states of DC, GA, MA, TX, VA and the countries of Dominican Republic, INDIA, Japan, Poland, Spain, Taiwan.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OWB
510(K)s with Product Code = OWB
510(K)s with Product Code = OWB
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