Company: LivaNova USA Inc Date of Enforcement Report: 8/8/2018 Class II: PRODUCT NS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2 Recall Number: Z-2572-2018 REASON Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer. RECALLING FIRM/MANUFACTURER LivaNova USA Inc., Houston, TX on 7/25/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF...Read More

Company: ELITech Clinical Systems SAS Date of Enforcement Report: 8/8/2018 Class II: PRODUCT ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117 Recall Number: Z-2591-2018 REASON ELITech Clinical Systems SAS initiated this recall because some users of ENVOY...Read More

Company:ELITech Clinical Systems SASDate of Enforcement Report 8/8/2018 Class lI: PRODUCT ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117 Recall Number: Z-2591-2018 REASON ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/8/2018 Class lI: PRODUCT SOMATOM Spirit(Model 10045692 ) Recall Number: Z-2478-2018 REASON A potential risk of unnecessary radiation exposure due to a software issue. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 2/1/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/8/2018 Class lI: PRODUCT SOMATOM Perspective (Model 10495568) Recall Number: Z-2474-2018 REASON A potential risk of unnecessary radiation exposure due to a software issue. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 2/1/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/8/2018 Class lI: PRODUCT SOMATOM Perspective 16 (Model 10891666) Recall Number: Z-2475-2018 REASON A potential risk of unnecessary radiation exposure due to a software issue. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 2/1/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/8/2018 Class lI: PRODUCT SOMATOM Emotion 16 (10165977) Recall Number: Z-2473-2018 REASON A potential risk of unnecessary radiation exposure due to a software issue. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 2/1/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/8/2018 Class lI: PRODUCT SOMATOM Scope Power (Model 10967888) Recall Number: Z-2477-2018 REASON A potential risk of unnecessary radiation exposure due to a software issue. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 2/1/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/8/2018 Class lI: PRODUCT SOMATOM Scope ( Model 10967666) Recall Number: Z-2476-2018 REASON A potential risk of unnecessary radiation exposure due to a software issue. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 2/1/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/8/2018 Class lI: PRODUCT SOMATOM Emotion 6 (Model 10165888) Recall Number: Z-2472-2018 REASON A potential risk of unnecessary radiation exposure due to a software issue. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 2/1/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More

Company:LivaNova USA Inc Date of Enforcement Report 8/8/2018 Class lI: PRODUCT NS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2 Recall Number: Z-2572-2018 REASON Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer. RECALLING FIRM/MANUFACTURER LivaNova USA Inc., Houston, TX on 7/25/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT...Read More

Company: Human Design Medical LLC Date of Enforcement Report: 8/1/2018 Class III: PRODUCT Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Recall Number: Z-2530-2018 REASON Some Vivo 65 devices have an unreleased version of the Firmware...Read More

Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 7/25/2018 Class II: PRODUCT RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 Product Usage RayStation is a software system designed for treatment planning and analysis of radiation therapy. Recall Number: Z-2554-2018 REASON The firm has...Read More

Company: Forte Automation Systems Inc. Date of Enforcement Report: 8/1/2018 Class II: PRODUCT Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of...Read More

Company: Abbott Laboratories, Inc. Date of Enforcement Report: 8/1/2018 Class II: PRODUCT CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000 Recall Number: Z-2522-2018 REASON Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems...Read More

Also states the new annual registration fees. Keep in mind, businesses with gross revenue under USD $100 million qualify for the reduced small business fees listed.Read More

Company: Forte Automation Systems Inc. Date of Enforcement Report 8/1/2018 Class II: PRODUCT Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of...Read More

Company:Human Design Medical Llc Date of Enforcement Report 8/1/2018 Class lII: PRODUCT Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Recall Number: Z-2530-2018 REASON Some Vivo 65 devices have an unreleased version of the Firmware upgrade...Read More

Company:RAYSEARCH LABORATORIES AB Date of Enforcement Report 7/25/2018 Class lI: PRODUCT RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 Product Usage RayStation is a software system designed for treatment planning and analysis of radiation therapy. Recall Number: Z-2554-2018 REASON The firm has learned...Read More

Company: Abbott Laboratories, Inc. Date of Enforcement Report 8/1/2018 Class lI: PRODUCT CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000 Recall Number: Z-2522-2018 REASON Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems...Read More

FDA provides examples of cleared Mobile Medical Apps.Read More

Dip.io was cleared for clinical urinalysis. The device includes test strips and a color coded card that is readable by smartphone to provide a result for several conditions including infection.Read More

Company: Tandem Diabetes Care Inc. Date of Enforcement Report 7/25/2018 Class II: PRODUCT t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B. Recall Number: Z-2471-2018 REASON The fuel gauge, the component that reads and reports the battery parameters to the pump, could provide...Read More

Company: GE Medical Systems Ultrasound & Primary Care Diagnostics, LL Date of Enforcement Report: 7/25/2018 Class II: PRODUCT T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for...Read More

Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 7/25/2018 Class II: PRODUCT RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A)Product Usage:RayStation is a software system designed for treatment planning and analysis of radiation therapy....Read More

Company: Intel-GE Care Innovations LLC Date of Enforcement Report: 7/25/2018 Class II: PRODUCT Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the...Read More

Company: Zeiss, Carl Inc. Date of Enforcement Report: 7/25/2018 Class II: PRODUCT Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope Recall Number: Z-2441-2018 REASON Under certain circumstances, the firmware makes it possible for the Disinfection unit UV (432332-9020-000) to activate outside of the Celldiscoverer 7 housing. This may result in exposure of the users...Read More

Company:GE Medical Systems Ultrasound & Primary Care Diagnostics, LL Date of Enforcement Report 7/25/2018 Class lI: PRODUCT T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity....Read More

Company:Tandem Diabetes Care Inc. Date of Enforcement Report 7/25/2018 Class lI: PRODUCT t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B. Recall Number: Z-2471-2018 REASON The fuel gauge, the component that reads and reports the battery parameters to the pump, could provide inaccurate...Read More

Company:RAYSEARCH LABORATORIES AB Date of Enforcement Report 7/25/2018 Class lI: PRODUCT RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A)Product Usage:RayStation is a software system designed for treatment planning and analysis of radiation therapy. Recall...Read More

Company:Zeiss, Carl Inc. Date of Enforcement Report 7/25/2018 Class lI: PRODUCT Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope Recall Number: Z-2441-2018 REASON Under certain circumstances, the firmware makes it possible for the Disinfection unit UV (432332-9020-000) to activate outside of the Celldiscoverer 7 housing. This may result in exposure of the users to...Read More

Company:Intel-GE Care Innovations LLC Date of Enforcement Report 7/25/2018 Class lI: PRODUCT Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home....Read More

Company: Steris Corporation Date of Enforcement Report: 7/18/2018 Class II: PRODUCT Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theatre shoes and other miscellaneous reusable items used in...Read More

Company: Ion Beam Applications S.A. Date of Enforcement Report: 7/18/2018 Class II: PRODUCT Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. Recall Number: Z-2424-2018 REASON Correction vector confirmation message...Read More

Company:Steris Corporation Date of Enforcement Report 7/18/2018 Class lI: PRODUCT Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theatre shoes and other miscellaneous reusable items used in the...Read More

Company:Ion Beam Applications S.A. Date of Enforcement Report 7/18/2018 Class lI: PRODUCT Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. Recall Number: Z-2424-2018 REASON Correction vector confirmation message is...Read More

Yuki Gosei Kogyo Co., Ltd. Date:7/17/18 Data Integrity Remediation: Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. We strongly recommend that you retain a qualified consultant to assist in your remediation. In response to this letter, provide the...Read More

Company: Medtronic Inc. Date of Enforcement Report: 7/11/2018 Class II: PRODUCT Medtronic MiniMed Paradigm Vea Insulin Pump Product Catalog Number: MMT-554, MMT-754 Recall Number: Z-2377-2018 REASON Medtronic notified customers/users of MiniMed” Paradigm” Veo” insulin pump that the pump has an error that impacts the Arabic language translation.This translation error occurs in the Predictive Alerts setting...Read More

Company: GE Healthcare Finland Oy Date of Enforcement Report 7/11/2018 Class II: PRODUCT GE Healthcare CARESCAPE Monitor B650 Recall Number: Z-2340-2018 REASON When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not...Read More

Company:GE Healthcare Finland Oy Date of Enforcement Report 7/11/2018 Class lI: PRODUCT GE Healthcare CARESCAPE Monitor B650 Recall Number: Z-2340-2018 REASON When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be...Read More

Company:Medtronic Inc. Date of Enforcement Report 7/11/2018 Class lI: PRODUCT Medtronic MiniMed Paradigm Vea Insulin Pump Product Catalog Number: MMT-554, MMT-754 Recall Number: Z-2377-2018 REASON Medtronic notified customers/users of MiniMed” Paradigm” Veo” insulin pump that the pump has an error that impacts the Arabic language translation.This translation error occurs in the Predictive Alerts setting screen,...Read More

Company:Spacelabs Healthcare, Ltd Date of Enforcement Report 8/10/2018 Class l: PRODUCT The Arkon Anesthesia Delivery System is intended for use in hospitals and operating rooms. It may be used to deliver oxygen, air, and nitrous oxide in a controlled manner to various patient breathing circuits (accessory sets that include tubing and breathing bags) with or...Read More

Our newsletter in pdf form lists items added to the web site from mid-April 2017 through June 2018. It serves as an easy reference to find new or updated items that may be of interest to you. Please search the library to see all items posted as the newsletter only lists new or updated ones. SoftwareCPR-June2018NewsletterRead More

Company: Baxter (Claris Injectables Ltd.) Date: 7/5/18 Data Integrity Remediation: Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. In response to this letter provide the following. A. A comprehensive investigation into the extent of the inaccuracies in data,...Read More

Baxter (Claris Injectables Ltd.) Product: drug manufacturing facility Date:7/5/18 Data Integrity Remediation Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. In response to this letter provide the following. A. A comprehensive investigation into the extent of the inaccuracies...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class II: PRODUCT Artis zeego, Material no. 10280959 Recall Number: Z-2314-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class II: PRODUCT Artis zee MP, Material no. 10094139,, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2313-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class II: PRODUCT Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2311-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 7/4/2018 Class II: PRODUCT Artis zee floor MN, Material no. 10094142, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2312-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 7/4/2018 Class II: PRODUCT Artis zee ceiling, Material no. 10094137, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2310-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although...Read More