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Class 2 Device Recall Giraffe Shuttle |
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Date Initiated by Firm |
April 02, 2020 |
Date Posted |
May 22, 2020 |
Recall Status1 |
Completed |
Recall Number |
Z-2111-2020 |
Recall Event ID |
85536 |
510(K)Number |
K101788
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Product Classification |
Incubator, neonatal - Product Code FMZ
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Product |
Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808. |
Code Information |
Serial numbers: GSHW60086, GSHX60001, GSHX60014, GSHY70002-GSHY70195, GSHZ70101-GSHZ70108, MAAP50034, MAAQ50170, MAAR50021, MAAT50013, MAAT60045, MAAU61029, MAAU61040 and MAAV6059. |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact |
800-437-1171
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Manufacturer Reason for Recall |
During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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510(K) Database |
510(K)s with Product Code = FMZ and Original Applicant = OHMEDA MEDICAL
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