Carescape ONE recall

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?

Model: 2087075-001 Serial Numbers: SNA20210164SA, SNA20210031SA, SNA20210045SA, SNA20210064SA, SNA20210319SA, SNA20210330SA, SNA20210348SA, SNA20210361SA, SNA20210362SA, SNA20210375SA, SNA20210376SA, SNA20210377SA, SNA20220003SA, SNA20220005SA, SNA20220007SA, SNA20220018SA, SNA20220022SA, SNA20220026SA, SNA20220045SA, SNA20220047SA, SNA18140024SA, SNA18340072SA, SNA18370025SA, SNA18380001SA, SNA18390009SA, SNA18430002SA, SNA18430059SA, SNA18430088SA, SNA18430116SA, SNA19390023SA, SNA19400056SA, SNA19400143SA, SNA19440048SA, SNA19440069SA, SNA19440071SA, SNA19440122SA, SNA19450008SA, SNA19450025SA, SNA19450128SA, SNA19450136SA, SNA19500072SA, SNA19500073SA, SNA19500080SA, SNA19500084SA, SNA19500086SA, SNA19510001SA, SNA19510005SA, SNA19510007SA, SNA19510012SA, SNA19510027SA, SNA19510053SA, SNA19510055SA, SNA19510103SA, SNA20020119SA, SNA20030070SA, SNA20030071SA, SNA20170022SA, SNA20170080SA, SNA20170082SA, SNA20170112SA, SNA20170113SA, SNA20170116SA, SNA20170117SA, SNA20170118SA, SNA20170120SA, SNA20170131SA, SNA20170134SA, SNA20170136SA, SNA20170139SA, SNA20170145SA, SNA20170160SA, SNA20170161SA, SNA20170164SA, SNA20170166SA, SNA20170168SA, SNA20170169SA, SNA20170171SA, SNA20170173SA, SNA20170176SA, SNA20170181SA, SNA20170182SA, SNA20170194SA, SNA20170197SA, SNA20170198SA, SNA20170232SA, SNA20170237SA, SNA20170264SA, SNA20180002SA, SNA20180008SA, SNA20180009SA, SNA20180011SA, SNA20180012SA, SNA20180017SA, SNA20180018SA, SNA20180023SA, SNA20180025SA, SNA20180026SA, SNA20180027SA, SNA20180028SA, SNA20180029SA, SNA20180030SA, SNA20180031SA, SNA20180032SA, SNA20180040SA, SNA20180042SA, SNA20180043SA, SNA20180044SA, SNA20180071SA, SNA20180073SA, SNA20180074SA, SNA20180075SA, SNA20180076SA, SNA20180080SA, SNA20180096SA, SNA20180101SA, SNA20180102SA, SNA20180109SA, SNA20180117SA, SNA20180144SA, SNA20180161SA, SNA20180162SA, SNA20190321SA, SNA20190331SA, SNA18140004SA, SNA18140005SA, SNA18140007SA, SNA18240025SA, SNA18240026SA, SNA18240030SA, SNA18240032SA, SNA18240044SA, SNA18240051SA, SNA18240054SA, SNA18240079SA, SNA18250010SA, SNA18250012SA, SNA18250017SA, SNA18250023SA, SNA18250026SA, SNA18250033SA, SNA18250034SA, SNA18250036SA, SNA18250044SA, SNA18250061SA, SNA18250072SA, SNA18250075SA, SNA18250078SA, SNA18250080SA, SNA18250081SA, SNA18250082SA, SNA18250086SA, SNA18250092SA, SNA18250093SA, SNA18440051SA, SNA18450094SA, SNA18450098SA, SNA18460013SA, SNA18460040SA, SNA18460072SA, SNA18460075SA, SNA18460083SA, SNA18460086SA, SNA18460089SA, SNA18460101SA, SNA19040008SA, SNA19050016SA, SNA19050025SA, SNA19050028SA, SNA19050030SA, SNA19050031SA, SNA19050033SA, SNA19050038SA, SNA19050043SA, SNA19050044SA, SNA19050045SA, SNA19050046SA, SNA19050049SA, SNA19050050SA, SNA19070071SA, SNA19070072SA, SNA19070073SA, SNA19070074SA, SNA19490074SA, SNA19500037SA, SNA19500043SA, SNA19500054SA, SNA19500059SA, SNA19510003SA, SNA20140029SA, SNA20140031SA, SNA20190324SA, SNA19500131SA, SNA20030120SA, SNA20040052SA, SNA20170179SA, SNA20170195SA, SNA20170203SA, SNA20180054SA, SNA20180057SA, SNA20180059SA, SNA20180077SA, SNA20180100SA, SNA20180103SA, SNA20180104SA, SNA20180113SA, SNA20180115SA, SNA20180142SA, SNA20180145SA, SNA20180146SA, SNA20180147SA, SNA20180154SA, SNA20180158SA, SNA20180163SA, SNA20180168SA, SNA20180183SA, SNA20180202SA, SNA20190024SA, SNA20190026SA, SNA20190030SA, SNA20190034SA, SNA20190038SA, SNA20190056SA, SNA20190057SA, SNA20190059SA, SNA20190060SA, SNA20190063SA, SNA20190106SA, SNA20190107SA, SNA20190109SA, SNA20190112SA, SNA20190114SA, SNA20190115SA, SNA20190116SA, SNA20190117SA, SNA20190119SA, SNA20190120SA, SNA20190121SA, SNA20190122SA, SNA20190124SA, SNA20190126SA, SNA20190127SA, SNA20190130SA, SNA20190131SA, SNA20190132SA, SNA20190133SA, SNA20190134SA, SNA20190137SA, SNA20190141SA, SNA20190142SA, SNA20190143SA, SNA20190144SA, SNA20190145SA, SNA20190146SA, SNA20190147SA, SNA20190148SA, SNA20190149SA, SNA20190152SA, SNA20190153SA, SNA20190155SA, SNA20190156SA, SNA20190159SA, SNA20190161SA, SNA20190174SA, SNA20190201SA, SNA20190204SA, SNA20190206SA, SNA20190209SA, SNA20190210SA, SNA20190214SA, SNA20190216SA, SNA20190217SA, SNA20190218SA, SNA20190219SA, SNA20190220SA, SNA20190221SA, SNA20190222SA, SNA20190223SA, SNA20190229SA, SNA20190230SA, SNA20190231SA, SNA20190232SA, SNA20190233SA, SNA20190235SA, SNA20190236SA, SNA20190237SA, SNA20190238SA, SNA20190239SA, SNA20190240SA, SNA20190247SA, SNA20190279SA, SNA20190289SA, SNA20190328SA, SNA20190339SA, SNA20200031SA, SNA20200081SA, SNA20200403SA.

Product

CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a…

Recalling firm

GE Healthcare, LLC

Quantity

8,414 units

Distribution

Worldwide distribution - US Nationwide distribution including in the states of MT, NC, TX and WI. The countries of Australia, Austria, Bahrain,Belgium, Bolivia, Brazil ,Canada, Chile, Check Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Malta, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Russia, Saudi Arabia, Singapore, Saint Martin, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, United Arab Emirates, United Kingdom.

Recall date

August 12, 2020

Classification

Class II

Status

Terminated

Agency

FDA (device)