FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
- Recall number
- Z-2111-2020
- Recalling firm
- GE Healthcare, LLC
- Product
- Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
- Status
- Terminated
- Initiated
- 2020-04-02
- Posted
- 2020-05-22
- Terminated
- 2024-05-06
- Reason
- During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor.
- Root cause
- Device Design
- Action
- GE Healthcare notified customers on 04/02/2020 via "Urgent Medical Device Correction" letter. The recall letter identified the affected product and serial numbers. The firm instructed the users to discontinue use of the product if at any time they smell a gas odor. GE Healthcare will correct all affected products at a later date when the correction is available at no cost.
- Quantity
- 204 units.
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, LA, MD, MI, MS, NC, ND, NM, NV, NY, OH, Ok, OR, PA, SC, TN, TX, VA, WA, WI and WV.
- Lot, serial or model codes
- Serial numbers: GSHW60086, GSHX60001, GSHX60014, GSHY70002-GSHY70195, GSHZ70101-GSHZ70108, MAAP50034, MAAQ50170, MAAR50021, MAAT50013, MAAT60045, MAAU61029, MAAU61040 and MAAV6059.
- 510(k) numbers
- ["K101788"]
- PMA numbers
- not on file
- Product code
- FMZ
- 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