{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "168705", "product_res_number": "Z-0222-2020", "event_date_initiated": "2018-10-01", "event_date_created": "2019-10-25", "recall_status": "Terminated", "event_date_terminated": "2020-10-01", "res_event_number": "81439", "product_code": "LJS", "k_numbers": [ "K170934" ], "product_description": "C3 Wave App, v. 2.0.5", "code_info": "v. 2.0.5; all units", "firm_fei_number": "2518902", "recalling_firm": "Medical Components, Inc dba MedComp", "address_1": "1499 Delp Dr", "city": "Harleysville", "state": "PA", "postal_code": "19438-2936", "additional_info_contact": "Compliance Department\n215-256-9191", "reason_for_recall": "When the iPad is updated with Apple\niOS software version 12, the C3 application malfunctions. Upon launching a new procedure, the ECG waves\ndo not appear on the screen, in surface or internal mode. If the C3 application is not operating properly, the PICC procedure must be completed without using alternate methods to confirm PICC tip placement.", "root_cause_description": "Software Manufacturing/Software Deployment", "action": "On October 1, 2018, the firm notified its customers via Product Advisory Notification letter. The letter communicated to customers that the most recent iOS version (12) was incompatible with the C3 Wave app v. 2.0.5.\n\nThe firm released v.2.0.6 of the app on 10/3/2018, which was made available in the app store. Customers were asked to update both the iOS and the C3 app at the same time to avoid any issues within the app. Customers were provided with step-by-step directions on how to do this.\n\nIf you have any questions, please contact Recalls@medcompnet.com.", "product_quantity": "24", "distribution_pattern": "Distributed to accounts in AZ, CA, CO, FL, IL, LA, MA, ME, NC, OH, TN, VA, and WV. Foreign distribution to Canada, Croatia, Czech Republic, Great Britain, Greece, Italy, Netherlands, Slovenia, and Sweden.", "openfda": { "k_number": [ "K953256", "K172899", "K232571", "K142889", "K131687", "K121941", "K082481", "K954720", "K241587", "K180548", "K172511", "K983412", "K953436", "K041468", "K851243", "K143238", "K093366", "K051690", "K921755", "K092306", "K883313", "K210264", "K844080", "K961336", "K180567", "K930630", "K932433", "K031129", "K050931", "K122423", "K061289", "K895543", "K897168", "K113277", "K150448", "K993052", "K840742", "K042491", "K112896", "K926293", "K012902", "K072196", "K093252", "K091953", "K023374", "K093927", "K161765", "K833442", "K120981", "K200037", "K964556", "K100635", "K961155", "K131038", "K091670", "K063848", "K071361", "K131942", "K964929", "K241910", "K971999", "K971085", "K021704", "K034020", "K093775", "K963215", "K830406", "K110627", "K072391", "K213550", "K834299", "K951078", "K832774", "K972555", "K871998", "K132567", "K830256", 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