FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems,Inc: Spine Clamp, an accessory to the InstaTrak 3500 Plus system. Clamp is attached to the spine to provide a mounting point for a transmitter.
- Recall number
- Z-0155-05
- Recalling firm
- GE OEC Medical Systems,Inc
- Product
- Spine Clamp, an accessory to the InstaTrak 3500 Plus system. Clamp is attached to the spine to provide a mounting point for a transmitter.
- Status
- Terminated
- Initiated
- 2004-09-15
- Posted
- 2004-11-03
- Terminated
- 2011-07-07
- Reason
- Threads on this accessory spine clamp may become tight, which may make it difficult to install or remove.
- Root cause
- Other
- Action
- Consignees were notified by letter on 9/15/2004.
- Quantity
- 114 units
- Distribution
- AL, CO, CA, FL, GA, LA, IL, IN, MA, MD, MI, MS, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, WV, including one VA facility in TN. No military or foreign distribution.
- Lot, serial or model codes
- Part Number: GE 1005556.
- 510(k) numbers
- ["K040050"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1720753
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28