Z-0155-05

Spine Clamp, an accessory to the InstaTrak 3500 Plus system. Clamp is attached to the spine to provide a...

Name: Z-0155-05 Spine Clamp, an accessory to the InstaTrak 3500 Plus system. Clamp is attached to the spine to provide a...
Creator: GE OEC Medical Systems,Inc
Published: 2004-09-15
License: https://open.fda.gov/license/

GE Healthcare / initiated 2004-09-15 / Terminated

FDA source

GE OEC Medical Systems,Inc began a recall of Spine Clamp, an accessory to the InstaTrak 3500 Plus system. Clamp is attached to the spine to provide a mounting point for a transmitter on 2004-09-15. The reason FDA records is "Threads on this accessory spine clamp may become tight, which may make it difficult to install or remove". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0155-05
Status: Terminated
Initiated: 2004-09-15
Posted: 2004-11-03
Terminated: 2011-07-07
Recalling firm: GE Healthcare
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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Threads on this accessory spine clamp may become tight, which may make it difficult to install or remove.
FDA root cause: Other
Action: Consignees were notified by letter on 9/15/2004.
Quantity in commerce: 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.
Product codes and lots: Part Number: GE 1005556.

Product code LLZ

K040050Class IIInstatrak System with Multiple Dataset Navigation, Model It3500Ge Medical Systems Navigation and Visualization IN / cleared 2004-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)