Unique identifier: (b)(4).Ge healthcare (gehc) reported a field modification for this issue per 21 cfr 806 on 20 march 2019.The fda recall number is z-1846-2019 & z-1847-2019.Customers were sent a letter explaining the issue and requesting the customer to inspect the warmer bedside panel latch areas.Replacement of broken bedside panels will be provided by gehc.A set of warning labels will be supplied for application to the bedside panels.These labels will warn the user to not use the bedside panels for maneuvering the warmer and indicate the correct method of maneuvering the warmer.An addendum to the operation and maintenance manual will also be provided emphasizing the need to check and ensure that the bedside panels and latches are not cracked, broken, or damaged before every patient use.The addendum will also contain instructions to increase detectability of broken or cracked bedside panels.On june 14, 2019 a letter was sent to customers providing an additional addendum, labels, and wall poster.
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