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U.S. Department of Health and Human Services

Class 2 Device Recall CARESCAPE ONE

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  Class 2 Device Recall CARESCAPE ONE see related information
Date Initiated by Firm June 22, 2020
Date Posted August 04, 2020
Recall Status1 Open3, Classified
Recall Number Z-2750-2020
Recall Event ID 85979
510(K)Number K200494  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility.
Code Information 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.
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		 CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 host monitor.
FDA Determined
Cause 2		 Software Design Change
Action You can continue to use your CARESCAPE ONE to monitor patients. Follow the instructions below each time the CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 host monitor. 1. As per the User Manual, closely observe and monitor the patients clinical condition and ECG waveforms on the CARESCAPE B450/B650/B850 host monitor for V Fib during the Learning phase and for several minutes after the Learning phase to allow the algorithm to reach optimal detection performance. 2. As per the User Manual, if the Learning message on the host monitor does not clear after 30 seconds, select the Relearn QRS option from the ECG menu on the host monitor following these steps. ¿ Select the HR parameter window. ¿ Select Advanced > Page 1. ¿ Select Relearn QRS. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. After the CARESCAPE ONE Monitor has been updated, discontinue usage of any previous versions of CARESCAPE ONE software. Destroy any software media containing previous versions of CARESCAPE ONE software, including reimage, upgrade kits, and FRUs. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = GE Healthcare
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