Giraffe Shuttle. Upgrade Kits with part number 2109672-001… recallZ-2111-2020 · GE Healthcare, LLC · initiated Apr 2, 2020
Class II Terminated All recalls posted in May 2020
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2111-2020
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 2, 2020
- Posted by the FDA
- May 22, 2020
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 204 units.
- Product code
- FMZ
- FDA submissions
- K101788
- 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.
Product description
Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
Code information (models, lots, serial numbers)
Serial numbers: GSHW60086, GSHX60001, GSHX60014, GSHY70002-GSHY70195, GSHZ70101-GSHZ70108, MAAP50034, MAAQ50170, MAAR50021, MAAT50013, MAAT60045, MAAU61029, MAAU61040 and MAAV6059.
Other devices under the same FDA submission
1 device cleared under K101788 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Giraffe OmniBed Carestation CS1Datex-Ohmeda, Inc. · INCUBATOR, NEONATAL2 recalls217 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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