UroDiagnost Eleva, system code 708033
Reported: March 25, 2020 Initiated: December 30, 2019 #Z-1492-2020
Product Description
UroDiagnost Eleva, system code 708033
Reason for Recall
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Details
- Recalling Firm
- Philips North America, LLC
- Units Affected
- 4
- Distribution
- Nationwide domestic distribution. Foreign distribution worldwide.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
UroDiagnost Eleva, system code 708033. Recalled by Philips North America, LLC. Units affected: 4.
Why was this product recalled? ▼
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 25, 2020. Severity: Moderate. Recall number: Z-1492-2020.
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