Philips North America BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
Brand
Philips North America
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Philips North America is recalling BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems. due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
The following details were not provided by the FDA: corrective action details.
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026