Z-0416-2022Class II

Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and...

Name: Z-0416-2022 Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and...
Creator: Philips North America Llc
Published: 2021-11-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2021-11-19 / Terminated

FDA source

Philips North America Llc began a recall of Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including... on 2021-11-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0416-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-19
Posted: 2021-12-22
Terminated: 2024-02-07
Recalling firm: Philips North America LLC
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.
Product code: OWB Interventional Fluoroscopic X-Ray System
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 root cause: Other
Action: 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).
Quantity in commerce: USA: 5 systems R.O.W.: 15 systems
Distribution: 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.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0416-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0416-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-29	2021-12-22

Product code OWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)