Giraffe OmniBed Carestation CS1…

Date

Nov. 13, 2019

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

Ongoing

Filed by

GE Healthcare, LLC

Product

Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo regulate based on their own physiology.

Reason

Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.

Distribution pattern

Worldwide distributions - US Nationwide in the states of CA, CT, FL, ID, IL, KS, MI, NC, NC, NJ, NM, PA, TX, VA. Countries of China, France, Germany, Korea, Republic of China.

Quantity

59 devices (50 US, 9 OUS)

Codes and lots

Model Number: 2082844-001; Serial Number (UDI Number): TABY70690 (010084068211686221TABY7069011190610), TABY70692 (010084068211686221TABY7069211190611), TABY70708 (010084068211686221TABY7070811190612), TABY70719 (010084068211686221TABY7071911190613), TABY70709 (010084068211686221TABY7070911190612), TABY70724 (010084068211686221TABY7072411190614), TABY70722 (010084068211686221TABY7072211190614), TABY70718 (010084068211686221TABY7064211190603), TABY70717 (010084068211686221TABY7064411190603), TABY70712 (010084068211686221TABY7064511190603), TABY70678 (010084068211686221TABY7067811190607), TABY70725 (010084068211686221TABY7072511190615), TABY70672 (010084068211686221TABY7067211190607), TABY70686 (010084068211686221TABY7068611190610), TABY70688 (010084068211686221TABY7068811190610), TABY70697 (010084068211686221TABY7069711190611), TABY70726 (010084068211686221TABY7072611190616), TABY70729 (010084068211686221TABY7072911190616), TABY70645 (010084068211686221TABY7064711190604), TABY70647 (010084068211686221TABY7066011190605), TABY70646 (010084068211686221TABY7071211190613), TABY70644 (010084068211686221TABY7071711190613), TABY70642 (010084068211686221TABY7071811190613), TABY70732 (010084068211686221TABY7073211190617), TABY70723 (010084068211686221TABY7072311190614), TABY70747 (010084068211686221TABY7074711190619), TABY70748 (010084068211686221TABY7074811190619), TABY70673 (010084068211686221TABY7067311190607), TABY70676 (010084068211686221TABY7067611190607), TABY70693 (010084068211686221TABY7069311190611), TABY70648 (010084068211686221TABY7064811190604), TABY70675 (010084068211686221TABY7067511190607), TABY70694 (010084068211686221TABY7069411190611), TABY70695 (010084068211686221TABY7069511190611), TABY70730 (010084068211686221TABY7073011190617), TABY70734 (010084068211686221TABY7073411190617), TABY70737 (010084068211686221TABY7073711190618), TABY70677 (010084068211686221TABY7067711190607), TABY70698 (010084068211686221TABY7069811190611), TABY70699 (010084068211686221TABY7069911190611), TABY70703 (010084068211686221TABY7070311190612), TABY70706 (010084068211686221TABY7070611190612), TABY70727 (010084068211686221TABY7072711190616), TABY70728 (010084068211686221TABY7072811190616), TABY70660 (010084068211686221TABY7064611190603), TABY70689 (010084068211686221TABY7068911190610), TABY70705 (010084068211686221TABY7070511190612), TABY70707 (010084068211686221TABY7070711190612), TABY70731 (010084068211686221TABY7073111190617), TABY70733 (010084068211686221TABY7073311190617), TABY70652 (Not Available), TABY70654 (Not Available), TABY70662 (Not Available), TABY70664 (Not Available), TABY70710 (Not Available), TABY70715 (Not Available), TABY70716 (Not Available), TABY70753 (Not Available), TABY70659 (Not Available), TABY70704 (010084068211686221TABY7070411190612), TABY70755 (010084068211686221TABY7075511190620), TABY70638 (Not Available), TABY70649 (Not Available), TABY70656 (Not Available), TABY70661 (Not Available), TABY70657 (Not Available), TABY70650 (Not Available), TABY70667 (Not Available), TABY70668 (Not Available), TABY70653 (Not Available), TABY70663 (Not Available), TABY70670 (Not Available), TABY70665 (Not Available), TABY70669 (Not Available), TABY70671 (Not Available), TABY70714 (Not Available), TABY70658 (Not Available), TABY70655 (Not Available), TABY70666 (Not Available), TABY70651 (Not Available).

Recall started

July 26, 2019

Device type

Incubator, Neonatal

Root cause (FDA)

Nonconforming Material/Component

What the company told customers

GE Healthcare notified customers on about 07/26/2019 via phone calls and a "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were instructed to immediately stop use of and segregate the affected devices, that GE Healthcare would correct all affected products at no cost, and a GE Healthcare representative will contact them to arrange for the correction. Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative. A second customer letter was sent on 08/05/2019 to all customer. The second letter contained the same instructions, but provided an updated list of affected serial numbers.

Recall number

Z-0281-2020

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

Source: FDA · Medical device enforcement report, recall number Z-0281-2020. The agency record governs; check it and the company before acting.