Recall Z-2276-2023— GE OEC Medical Systems, Inc
Class II · Ongoing
Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2023-05-15. It names 3 FDA 510(k) clearances: K132027, K111551, K021049. Product: OEC 9800 Systems with 9-inch Image Intensifier. Reason: Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain..
- Recalling firm
- GE OEC Medical Systems, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-15
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
3 on FDA's record- K132027 — OEC 9800 PLUS
- K111551 — OEC(R) 9800, OEC(R) 9800 PLUS
- K021049 — OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
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
OEC 9800 Systems with 9-inch Image Intensifier
Reason for recall
Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
Data sourced from openFDA. This site is unofficial and independent of the FDA.