Z-1416-2023Class II

SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6

Name: Z-1416-2023 SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
Creator: Philips Medical Systems Nederland B.v.
Published: 2023-02-20
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2023-02-20 / Open, Classified / root cause: software

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6 on 2023-02-20. FDA classified it as Class II and gives the reason as "There are technical issues related to signal generation and processing, which can lead to inaccurate presentations". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1416-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-20
Posted: 2023-04-20
Recalling firm: Philips Medical Systems Nederland B.V.
Product: SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
Root cause tag: software
FDA root cause: Software design
Action: A recall notification letter was issued February 20, 2023. The Urgent Medical Device Correction letter includes the following instructions for the Customer: " Stop using SmartPerfusion and 2D Perfusion. NOTE: This message does not impact (other parts of) the Philips Allura or Azurion systems or other tools within the Interventional Workspot. The Philips Allura and Azurion systems as well as other Interventional Workspot tools may continue to be used. " Place the Urgent Medical Device Correction Letter with the documentation of the system. " Circulate the notice to all users so that they are aware of the product issue. " Return the reply form attached to the Urgent Medical Device Correction letter to Philips to confirm that the users of the system have reviewed and understood it.
Quantity in commerce: 1461 units (236 US, 1225 OUS)
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: UDI: (01)00884838088566 SmartPerfusion with Allura Xper or Azurion model number: 722003, 722006, 722008, 722010, 722012, 722013, 722020, 722023, 722026, 722027 722028, 722029, 722035, 722038, 722039, 722058, 722059, 722064, 722067 722068, 722078, 722079, 722223, 722224, 722225, 722226, 722227 and 722228. Software license key: 459801530271 sw key SmartPerfusion

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1416-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1416-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-20
Z-1417-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-20

Product code OWB

K181966Class IISmartPerfusionPhilips Medical Systems Nederlands B.V. / cleared 2018-08-17

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)