Senographe Pristina
Reported: February 14, 2024 Initiated: December 26, 2023 #Z-0862-2024
Product Description
Senographe Pristina
Reason for Recall
X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
Details
- Recalling Firm
- GE Medical Systems, SCS
- Units Affected
- 180 units (60 US; 120 OUS)
- Distribution
- Us Nationwide-Worldwide Distribution
- Location
- Buc
Frequently Asked Questions
What product was recalled? ▼
Senographe Pristina. Recalled by GE Medical Systems, SCS. Units affected: 180 units (60 US; 120 OUS).
Why was this product recalled? ▼
X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2024. Severity: Moderate. Recall number: Z-0862-2024.
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