—#190752

Product

Philips 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.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K130842, K141979, K161563
Affected lot / code info: 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;

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

Philips 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).

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of DC, GA, MA, TX, VA and the countries of Dominican Republic, INDIA, Japan, Poland, Spain, Taiwan.

Timeline

Recall initiated: 2021-11-19
Terminated: 2024-02-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190752. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.