{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "64365", "product_res_number": "Z-0041-2008", "event_date_initiated": "2007-08-01", "event_date_posted": "2007-10-11", "recall_status": "Terminated", "event_date_terminated": "2008-05-14", "res_event_number": "44791", "product_code": "KPS", "k_numbers": [ "K032063" ], "product_description": "PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging.", "code_info": "Serial numbers: C3, P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P14, P002-B-070119-01, P002-B-070316-01, P002-B-070423-01, P002-B-070531-01, P002-B-070629-01, P002-B-070712-01", "firm_fei_number": "3005945241", "recalling_firm": "Naviscan PET Systems", "address_1": "11180 Roselle St Ste A 11180 Roselle St", "address_2": "Ste A", "city": "San Diego", "state": "CA", "postal_code": "92121-1211", "additional_info_contact": "Heather Jalisi\n858-587-3641 Ext. 114", "reason_for_recall": "Naviscan has identified a potential safety issue with all versions of PEM View Software commonly used for analyzing patient images acquired on the PEMFIex product line.\n1. The Positron Emission Mammography Standardized Uptake Value (PEMSUV) and distance measurements for the product mentioned above may be inaccurate if a zoomed image has been opened, measurement tools are used, and the applet rema", "root_cause_description": "Software design", "action": "Telephone notification regarding issues #1 and #2 were carried out on August 1 and 2, 2007 and included instructions for a validated work-around to avoid the software issues. Written notifications with these same validated work-around instructions were sent on August 2, 2007 via certified mail. Customers were notified that Naviscan has identified a potential safety issue with all versions of PEM View Software.\n\nIssue #3 was identified after the notification to customers for issues #1 and #2. Telephone notification regarding issues #3 was carried out via telephone and certified mailing beginning August 16, 2007. Customers were informed that Naviscan is preparing software to resolve these issues and that they would be contacted by Naviscan Customer Support to ensure they thoroughly understand the issues and the recommended procedure to prevent these issues from occurring. \n\nIf customers have any questions they were instructed to contact Naviscan Customer Support at 1-888-628-4159 or service@navsicanpet.com.", "product_quantity": "19 units", "distribution_pattern": "Nationwide.", "openfda": { "k_number": [ "K981553", "K033254", "K926206", "K082506", "K093514", "K980715", "K042880", "K033782", "K123599", "K243186", "K011572", "K013353", "K923736", "K973396", "K991129", "K070589", "K041543", "K925186", "K936001", "K050366", "K162736", "K914296", "K161674", "K926133", "K261315", "K972509", "K121019", "K090178", "K201933", "K982387", "K181468", "K971878", "K123646", "K042863", "K221932", "K032063", "K013496", "K100714", "K172609", "K260524", "K925330", "K051549", "K923309", "K130451", "K110507", 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"3014954414", "3010703925", "3014343100", "3014470527" ], "device_name": "System, Tomography, Computed, Emission", "medical_specialty_description": "Radiology", "regulation_number": "892.1200", "device_class": "2" } } ] }