24
Sep
2008

Inc, Cl Il CAS Medical Systems

0

Company: CAS Medical Systems, Inc,
Date of Enforcement Report 9/24/2008
Class:ll

PRODUCT
740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, and 740M-3NN. Indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adults, pediatric and neonatal patients, in the care of health professionals, Recall # Z-2203-2008p>

REASON
Software: Audible alarm may be silenced if changed from the factory setting.

RECALLING FIRM/MANUFACTURER
CAS Medical Systems, Inc., Branford, CT, by letter on June 24, 2008, Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
820 units

DISTRIBUTION
Nationwide, Canada, Jordan, UK, France and Taipei

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

  • Agile principles that align well with medical
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3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offerings:

  • TBD
See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

 

Medical Device Cybersecurity (Public or Private)

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2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

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