Giraffe Shuttle…

Date

June 3, 2020

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

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

Reason

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.

Quantity

204 units.

Codes and lots

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

Recall started

April 2, 2020

Device type

Incubator, Neonatal

Root cause (FDA)

Device Design

What the company told customers

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 number

Z-2111-2020

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2111-2020. The agency record governs; check it and the company before acting.