FDA Medical Device Recalls (openFDA)
GE Medical Systems, LLC: Sterile, Drape, Headset, Upper, Part Number 888945-01.
- Recall number
- Z-1708-2009
- Recalling firm
- GE Medical Systems, LLC
- Product
- Sterile, Drape, Headset, Upper, Part Number 888945-01.
- Status
- Terminated
- Initiated
- 2008-08-15
- Posted
- 2009-09-01
- Terminated
- 2012-05-15
- Reason
- GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state. Eleven complaints and 3 MDR's have been filed. No illness or injuries reported.
- Root cause
- Packaging process control
- Action
- GE Healthcare issued an Urgent Recall Notice dated August 15, 2008. The letter described the problem, provided a list of products, instructed customers to stop using the products and to return or dispose. To receive credit, customers must complete the attached product return form and include it in the package with returned items. All customers were asked to complete and fax back the attached response form.
- Quantity
- 50 each
- Distribution
- Nationwide Distribution -- AZ, CA, FL, MD, NY, OR, PA, SC and TX.
- Lot, serial or model codes
- all lots
- 510(k) numbers
- ["K021049","K782155","K820692","K970185","K993687"]
- PMA numbers
- not on file
- Product code
- MMP
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- 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