Recall Z-2275-2023— GE OEC Medical Systems, Inc

Name: FDA recall Z-2275-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-15

Class II · Ongoing

Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2023-05-15. It names one FDA 510(k) clearance: K003837. Product: OEC Flexiview 8800 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

1 on FDA's record

K003837 — FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEMGe Oec Medical Systems·cleared 2001-03-12

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 Flexiview 8800 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.