Z-2716-2024 Class II Ongoing
FDA device recall Z-2716-2024 was initiated by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on Aug 8, 2024 and is designated Class II. Reason for recall: A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt. The recall status is ongoing. Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 28, 2024
- Initiation Date
- Aug 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
Reason for Recall
A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of IL and OR. The countries of Hungary, Ireland, Poland, UK.
Code Information
Serial Numbers: 111 138 467 817 2928 269
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2716-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026