Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280
Reported: February 28, 2024 Initiated: February 6, 2024 #Z-1176-2024
Product Description
Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280
Reason for Recall
Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.
Details
- Recalling Firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Units Affected
- 14 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of NY, PA, PR, TN, TX, VA, WA and the countries of Algeria, Armenia, Austria, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Korea, Republic of Kuwait, Lithuania, Macao, Macedonia, Malaysia, Morocco, Netherlands, Norway, Oman, Palestine, State of Panama, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom.
- Location
- Best, N/A
Frequently Asked Questions
What product was recalled? ▼
Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280. Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Units affected: 14 units.
Why was this product recalled? ▼
Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 28, 2024. Severity: Moderate. Recall number: Z-1176-2024.
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