Z-0224-2024Class II

BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems

Name: Z-0224-2024 BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems
Creator: Philips North America
Published: 2023-10-04
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-10-04 / Open, Classified / root cause: design

FDA source

Philips North America began a recall of BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems on 2023-10-04. FDA classified it as Class II and gives the reason as "Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer)...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0224-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-04
Posted: 2024-09-30
Recalling firm: Philips North America LLC
Product: BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
Root cause tag: design
FDA root cause: Device Design
Distribution: United States Territories of Puerto Rico, Guam, and Virgin Islands
Product codes and lots: Endura 2.2 1195 Endura 2.2 1202 Endura 2/3 95 Endura 2/3 429 Endura 2/3 443 Endura 2/3 868 Endura 2/3 871 Endura 2/3 998 Endura 2/3 1231 Pulsera 2.2 1623 Pulsera 2.2 1731 Pulsera 2.2 2501 Pulsera 2.2 2507 Pulsera 2.2 641 Pulsera 2.2 884 Pulsera 2.2 882 Pulsera 2.2 1483 Pulsera 2.2 883 Pulsera 2.2 1711 Pulsera 2.3 234 Pulsera 2.3 454 Pulsera 2.3 547 Pulsera 2.3 546 Pulsera 2.3 1044 Pulsera 2.3 1205 Pulsera 2.3 1774 Pulsera 2.3 2709 Pulsera 2.3 3880 Pulsera 2.3 13817 Pulsera 2.3 13818

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0224-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0224-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09
Z-0226-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09
Z-0227-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09
Z-0228-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09
Z-0229-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09
Z-0230-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09

Product code OWB

K010435Class IIPhilips Bv Pulsera/enduraPhilips Medical Systems, Inc. / cleared 2001-03-12

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)