Z-2111-2020Class II

Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808

Name: Z-2111-2020 Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808
Creator: GE Healthcare, LLC
Published: 2020-04-02
License: https://open.fda.gov/license/

GE Healthcare / initiated 2020-04-02 / Terminated / root cause: design

FDA source

GE Healthcare, LLC began a recall of Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808 on 2020-04-02. FDA classified it as Class II and gives the reason as "During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2111-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-02
Posted: 2020-05-22
Terminated: 2024-05-06
Recalling firm: GE Healthcare
Product: Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
Product code: FMZ Incubator, Neonatal
Reason for recall: During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: Serial numbers: GSHW60086, GSHX60001, GSHX60014, GSHY70002-GSHY70195, GSHZ70101-GSHZ70108, MAAP50034, MAAQ50170, MAAR50021, MAAT50013, MAAT60045, MAAU61029, MAAU61040 and MAAV6059.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2111-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2111-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-22

Product code FMZ

K101788Class IIGiraffe OmnibedOhmeda Medical / cleared 2010-07-21

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)