BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
Summary
The FDA issued a Class II for BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery by Philips North America. Reason: 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.
Details
Source
Device Recall
External ID
Z-0224-2024
Action Date
2023-11-15
Status
Ongoing
Category
device
Product Description
BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
Lot/Code Info: 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
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.
Distribution
United States Territories of Puerto Rico, Guam, and Virgin Islands
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-04
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips North America has 126 FDA actions in our database, including 126 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America have FDA actions?
Philips North America has 126 FDA actions in our database, including 126 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0224-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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