FDAClass IIJuly 12, 2023

Giraffe OmniBed Carestation CS1 recall

Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f. M1145476, g.…

Why was Giraffe OmniBed Carestation CS1 recalled?

GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

a. Model Number 2082844-001-XXX; GTIN Numbers: 010084068211686221, 010084068211686221; All Lot/Serial Numbers. b. Model Number 2074920-001-XXXXXX; No GTIN Number; Serial Numbers: HDGR52137, HDGL50099, HDGT60164, HDGT60143, HDGT60142, HDGT60139, HDGT60138, HDGT60137, HDGU60753, HDGT60652, HDGU60069, HDGT60141, HDGU60156, HDGU60120, HDGU60119, HDGT60163, HDGT60703, HDGT60245, HDGT60160, HDGT60459, HDGT60246, HDGT60235, HDGU67645, HDGU60065, HDGU60063, HDGU60061, HDGU63122, HDGU63121, HDGU60062, HDGU57534, HDGU67533, HDGU67534, HDGT60460, HDGU67236, HDGT60249, HDGU60201, HDGU60570, HDGU60620, HDGU60023, HDGU60020, HDGT60612, HDGU60022, HDGU60571, HDGU60686, HDGU60202, HDGV60190, HDGW60244, HDGU67677, HDGU67676, HDGU67675, HDGU67280, HDGU67416, HDGU67415, HDGU67382, HDGU67377, HDGU67369, HDGU67366, HDGU67362, HDGU67289, HDGU67284, HDGU67282, HDGU63165, HDGU63167, HDGU63166, HDGV61084, HDGU67436, HDGU67423, HDGU67422, HDGU67421, HDGU67420, HDGU67419, HDGU67418, HDGU67414, HDGU67413, HDGU67381, HDGU67380, HDGU67379, HDGU67378, HDGU67370, HDGU67368, HDGU67367, HDGU67365, HDGU67363, HDGU67361, HDGU67360, HDGU67359, HDGU67358, HDGU67357, HDGU67304, HDGU67303, HDGU67302, HDGU67301, HDGU67300, HDGU67299, HDGU67298, HDGU67297, HDGU67296, HDGU67295, HDGU67294, HDGU67293, HDGU67292, HDGU67291, HDGU67290, HDGU67288, HDGU67287, HDGU67286, HDGU67285, HDGU67283, HDGU67281, HDGJ51159, HDGT60613, HDGT60614, HDGU60700, HDGU60703. c. Model Number M1050205; No GTIN Number; Serial Numbers: HDGV60148, HDGU60656, HDGU60658, HDGT60481, HDGS50047, HDGV60146. d. Model Number M1135822; No GTIN Number; Serial Numbers: HDGL51737, HDGL51738, HDGL51734, HDGM50736, HDGM50841, HDGL51735. e. Model Number M1145475; No GTIN Number; Serial Numbers: HDGM51813, HDGM52120, HDGM52119, HDGN50474, HDGN50472, HDGN50471, HDGN50469, HDGN50466, HDGN50464, HDGN50848, HDGN50847, HDGN50846, HDGN50845, HDGN50844, HDGQ50049, HDGR53203, HDGS51654, HDGS51653, HDGS51652, HDGS51651, HDGS51650, HDGS51649, HDGS51648, HDGS51647, HDGS51646, HDGS51645, HDGM51179, HDGQ50425, HDGN50465, HDGN50849, HDGN50467, HDGN50470, HDGN50475, HDGR52324, HDGR52323, HDGR52322, HDGR52321, HDGN50468. f. Model Number M1145476; No GTIN Number; Serial Numbers: HDGR52896. g. Model Number M1235957; No GTIN Number; Serial Numbers: HDGT60222. h. Model Number M1149051; No GTIN Number; Serial Numbers: HDGR53018, HDGR53085, HDGR52927, HDGR53086, HDGR53021. i. Model Number M1146098; No GTIN Number; Serial Numbers: HDGS52233, HDGS52234.

Product
Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f. M1145476, g.…
Recalling firm
DATEX--OHMEDA, INC.
Quantity
4,540 units
Distribution
Worldwide distribution.
Recall date
July 12, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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