GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822
Summary
The FDA issued a Class I for GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767 by Wipro GE Healthcare Private Ltd.. Reason: GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby T.
Details
Source
Device Recall
External ID
Z-0962-2024
Action Date
2024-02-21
Status
Ongoing
Category
device
Product Description
GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822
Lot/Code Info: ALL SERIAL NUMBERS
Quantity Affected: 17 units
Reason for Recall
GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-26
Company
Bengaluru, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Wipro GE Healthcare Private Ltd. has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Wipro GE Healthcare Private Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Wipro GE Healthcare Private Ltd. have FDA actions?
Wipro GE Healthcare Private Ltd. has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0962-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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