—#181185

Product

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

FDA product code: FMZ — Incubator, Neonatal
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K101788
Affected lot / code info: Serial numbers: GSHW60086, GSHX60001, GSHX60014, GSHY70002-GSHY70195, GSHZ70101-GSHZ70108, MAAP50034, MAAQ50170, MAAR50021, MAAT50013, MAAT60045, MAAU61029, MAAU61040 and MAAV6059.

Why it was recalled

During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-04-02
Posted by FDA: 2020-05-22
Terminated: 2024-05-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181185. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.