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Critical recall: Death or serious injury has been reported or is considered likely. Stop using this product now.

Wipro GE Healthcare Private Ltd. 2024-02-21 Health critical FDA
Health · FDA · Recall #FDA-Z-0957-2024

GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care… Recall

Issued February 21, 2024 · Wipro GE Healthcare Private Ltd.

In February 2024, Wipro GE Healthcare Private Ltd. recalled the GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.

Compiled by Maya Ellison, RecallCheckr

What this means for you

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.

What you should do

  1. 1 Stop using GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Wipro GE Healthcare Private Ltd. to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Wipro GE Healthcare Private Ltd.
Category
Health
Recall date
February 21, 2024
Units affected
Not reported
Sold at
Worldwide distribution.
Recall number
FDA-Z-0957-2024
Made in
India
Issuing agency
FDA

In context

  • Wipro GE Healthcare Private Ltd. has 1 recall in our database, including 1 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 737th Health recall we've logged in 2024.
Read the official FDA notice

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