Z-2111-2020 Class II Terminated

Recalled by GE Healthcare, LLC — Waukesha, WI

FDA device recall Z-2111-2020 was initiated by GE Healthcare, LLC on April 2, 2020 and is designated Class II. Reason for recall: During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor. The recall status is terminated (terminated May 6, 2024). Affected quantity: 204 units..

Recall Details

Product Type
Devices
Report Date
June 3, 2020
Initiation Date
April 2, 2020
Termination Date
May 6, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
204 units.

Product Description

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

Reason for Recall

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

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.

Code Information

Serial numbers: GSHW60086, GSHX60001, GSHX60014, GSHY70002-GSHY70195, GSHZ70101-GSHZ70108, MAAP50034, MAAQ50170, MAAR50021, MAAT50013, MAAT60045, MAAU61029, MAAU61040 and MAAV6059.