Day

August 8, 2018
08
Aug

Recall – CT Scanner

August 8, 2018
Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/8/2018 Class II: 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...
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08
Aug

Recall – CT Scanner

August 8, 2018
Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/8/2018 Class II: 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...
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08
Aug

Recall – CT Scanner

August 8, 2018
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 8/8/2018 Class II: 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...
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08
Aug

Recall – CT Scanner

August 8, 2018
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/8/2018 Class II: 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...
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08
Aug

Recall – CT Scanner

August 8, 2018
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 8/8/2018 Class II: 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...
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08
Aug

Recall – CT Scanner

August 8, 2018
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 8/8/2018 Class II: 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...
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08
Aug

Recall – CT Scanner

August 8, 2018
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 8/8/2018 Class II: 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...
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08
Aug

Recall – NS Therapy Programming System

August 8, 2018
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...
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08
Aug

Recall – Chemistry Analyzer

August 8, 2018
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...
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08
Aug

Recall – Cl II Siemens SOMATOM Spirit

August 8, 2018
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...
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08
Aug

Recall – Siemens SOMATOM Scope

August 8, 2018
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...
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08
Aug

Recall – Siemens SOMATOM Scope Power

August 8, 2018
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...
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08
Aug

Recall – Siemens SOMATOM Perspective 16 Cl II

August 8, 2018
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...
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08
Aug

Recall – Siemens SOMATOM Perspective (10495568) Cl II

August 8, 2018
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...
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08
Aug

Recall – Siemens SOMATOM Emotion 6 Model 10165888 Cl II

August 8, 2018
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
08
Aug

Recall – Siemens SOMATOM Emotion 16 (10165977) Cl II

August 8, 2018
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
08
Aug

Recall – NS Therapy Programming System

August 8, 2018
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...
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08
Aug

Recall – ENVOY 500 ISE CALIBRATOR Kit

August 8, 2018
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...
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62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

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