Recall Z-0862-2024— GE Medical Systems, SCS
Class II · Ongoing
Class II FDA medical device recall by GE Medical Systems, SCS, initiated 2023-12-26. It names 5 FDA 510(k) clearances: K211215, K193334, K182951 and 2 more. Product: Senographe Pristina. Reason: X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements..
- Recalling firm
- GE Medical Systems, SCS
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-26
- Firm location
- Buc, France
510(k) clearances named in this recall
5 on FDA's record- K211215 — SenoBright HD
- K193334 — Pristina Serena Bright
- K182951 — Pristina Serena 3D
- K173576 — Pristina Serena
- K162268 — Senographe Pristina
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.