Company: Acclarent, Inc. Date of Enforcement Report: 10/20/2023 Class II PRODUCT TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005 Recall Number: Z-0127-2024 REASON: When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended...Read More
Wavi Co. was issued a warning letter from the FDA for reason of “failure to perform validation of device software as required by 21 CFR 820.30(g).” More specifically, “Your firm distributed at least 90 WAVi Complete Systems consisting of WAVi Headsets, WAVi eSoc single use electrodes, electrode contacts, Electronic Processing Units [EPU], ear clips, Heart...Read More
Company: EITAN MEDICAL LTD Date of Enforcement Report: 10/19/2023 Class I PRODUCT Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001) Recall Number: Z-0094-2024 REASON: Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism. RECALLING FIRM/MANUFACTURER: EITAN MEDICAL LTD VOLUME...Read More
Company: OLEA MEDICAL Date of Enforcement Report: 10/18/2023 Class II PRODUCT Functional MR V1.0 Recall Number: Z-0122-2024 REASON: When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause file contents and associated series descriptions to not match, which could lead to...Read More
FDA issues a warning letter for Abiomed Inc. for the reason of “Our inspection also revealed the Impella Connect System device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act,...Read More
Company: Blue Belt Technologies, Inc Date of Enforcement Report: 10/05/2023 Class II PRODUCT Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299 Recall Number: Z-0041-2024 REASON: CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees...Read More
Company: Philips North America Llc Date of Enforcement Report: 09/29/2023 Class II PRODUCT EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380 Recall Number: Z-2654-2023 REASON: A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated. RECALLING...Read More
Company: Philips Healthcare Date of Enforcement Report: 09/29/2023 Class II PRODUCT Incisive CT, software version 5.0 Recall Number: Z-2520-2023 REASON: Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted surview for...Read More
Company: Medtronic Neuromodulation Date of Enforcement Report: 09/29/2023 Class II PRODUCT Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators. Recall Number: Z-2657-2023 REASON: The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the...Read More
Company: CareFusion 303, Inc. Date of Enforcement Report: 09/28/2023 Class II PRODUCT BD Pyxis MedBank MedPass Software, REF: 139088-01 Recall Number: Z-2646-2023 REASON: After dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed medication dose is still available for dispense, which could lead to...Read More
Company: Baxter Healthcare Corp. Date of Enforcement Report: 09/28/2023 Class II PRODUCT Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x. Recall Number: Z-2647-2023 REASON: Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System...Read More
Company: Exocad GmbH Date of Enforcement Report:9/25/2023 Class II PRODUCT exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents anatomy. Recall Number: Z-2633-2023 REASON: A software library filtering error has been discovered which occurs when...Read More
Sonesta Medical AB was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: “This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for,...Read More
By Ron Baerg and Mike Russell “You can pay me now, or you can pay me later” was the punch line of a memorable TV commercial by the FRAM® company about their oil filters around 50 years ago. The “me”: a car mechanic. Their point: paying (a little) now to replace your oil filter regularly...Read More
What does the US FDA expect in a premarket submission for description of the software design? In the recent June 2023 Guidance for Industry and Food and Drug Administration Staff titled, “Content of Premarket Submissions for Device Software Functions,” the FDA gives the following guidance. For lower risk devices, the manufacturer is not required to...Read More
Company: Diversatek Healthcare Date of Enforcement Report: 09/07/2023 Class III PRODUCT ZVU Functional GI Software, REF: ZVU-3 Recall Number: Z-2521-2023 REASON: GI software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. RECALLING FIRM/MANUFACTURER: Diversatek Healthcare VOLUME OF PRODUCT IN COMMERCE: 20 DISTRIBUTION: Worldwide – US Nationwide distribution in the states...Read More
Lex Inc. was issued a warning letter from the FDA for reason “of vulnerabilities in hardware and software, encompassing both networked and non-networked systems (e.g., programmable logic controller (PLC)).” More specifically, “a list of all software configurations (both equipment software and laboratory information management system (LIMS)) and versions, details of all user privileges, and oversight...Read More
Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 08/25/2023 Class II PRODUCT RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. Model Numbers: 5.0.0, 5.0.1, 5.1.1,5.1.2, 5.1.3, 6.0.0 Recall Number: Z-2464-2023 REASON:...Read More
Company: Stryker Corporation Date of Enforcement Report: 08/25/2023 Class II PRODUCT SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090. Recall Number: Z-2463-2023 REASON: Potential for current software to miscount when scanning in multiple...Read More
The Open Worldwide Application Security Project (OWASP) released a white paper titled OWASP Top 10 for LLM. The introduction states, The frenzy of interest of Large Language Models (LLMs) following of mass-market pre- trained chatbots in late 2022 has been remarkable. Businesses, eager to harness the potential of LLMs, are rapidly integrating them into their...Read More
Recalled Product Product Names: Oxylog 3000 Plus Emergency and Transport Ventilator Part Numbers: 5704811 and 5704813 Product Material Numbers: See Recall Database Entry Distribution Dates: April 30, 2012 to June 13, 2022 Devices Recalled in the U.S.: 300 Date Initiated by Firm: June 12, 2023 Device Use The Oxylog 3000 Plus Emergency and Transport Ventilator is...Read More
A former employee forges FDA clearance letters at a Philadelphia-area medical device manufacturer. Peter Stoll III pleaded guilty to one felony count of violating the Federal Food, Drug, and Cosmetic Act (FDCA) by causing the introduction of misbranded and adulterated medical devices into interstate commerce, in violation of 21 United States Code, Section 331(a) and 331(a)(2). ...Read More
Company: Medtronic Neuromodulation Date of Enforcement Report: 07/21/2023 Class II PRODUCT A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application.. Recall Number: Z-2226-2023 REASON: When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application...Read More
Company: Hamilton Medical, Inc. Date of Enforcement Report: 07/21/2023 Class I PRODUCT HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates. Recall Number: Z-2139-2023 REASON: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop...Read More
Company: Digisonics, Inc Date of Enforcement Report: 07/20/2023 Class II PRODUCT Digisonics OBView Versions 4.8.2 SP6 – 4.8.3, Ultrasound reporting software Recall Number: Z-2214-2023 REASON: Software issue RECALLING FIRM/MANUFACTURER: Digisonics, Inc VOLUME OF PRODUCT IN COMMERCE: 32 units DISTRIBUTION: US Distribution: AK, NH, WY, TX, NE, CA, MD, TX, OR IA, IL, MO, OR, NY,...Read More
