CARESCAPE ONE, Physiological Patient Monitor - Product… recallZ-2750-2020 · GE Healthcare, LLC · initiated Jun 22, 2020
Class II Terminated All recalls posted in August 2020
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Software Design Change
What the company is doing
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.
Recall details
- Recall number
- Z-2750-2020
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 22, 2020
- Posted by the FDA
- Aug 4, 2020
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 8,414 units
- Product code
- MHX
- FDA submissions
- K200494
- 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.
Product description
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 (models, lots, serial numbers)
Show the full code information (4k characters)
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.
Other devices under the same FDA submission
1 device cleared under K200494 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CARESCAPE ONE MBZ101GE Medical Systems Information Technologies, Inc. · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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