Recall Z-2279-2023— GE OEC Medical Systems, Inc

Name: FDA recall Z-2279-2023
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 6 FDA 510(k) clearances: K132027, K120613, K111551 and 3 more. Product: Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems. 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

6 on FDA's record

K132027 — OEC 9800 PLUSGe Oec Medical Systems, Inc.·cleared 2014-05-01
K120613 — OEC 9900 ELITEGe Healthcare Surgery GE Oec Medical Systems, Inc.·cleared 2012-04-06
K111551 — OEC(R) 9800, OEC(R) 9800 PLUSGe Oec Medical Systems, Inc.·cleared 2011-10-04
K073543 — OEC 9900 ELITEGe Oec Medical Systems·cleared 2008-05-02
K021049 — OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEMGe Oec Medical Systems·cleared 2002-04-17
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

Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems

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.