17

Feb

2010

Cl Il Guardian Services Software

0

Company:Stryker Imaging
Date of Enforcement Report 2/17/2010
Class:ll

PRODUCT
Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and 0240-020-022 (Office PACS Power). Intended use is to act as a medical data backup and disaster recovery plan. Recall # Z-0134-2010

REASON
Firm has determined Guardian Services does not contain 100% data backup for 12 OfficePACS Power customers on a daily basis.

RECALLING FIRM/MANUFACTURER
Stryker Imaging, Flower Mound, TX, by letter dated August 18, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
12 units

DISTRIBUTION
Nationwide

REASON
Demographic data, most notably allergy and precaution data, can be overwritten with incomplete data or blanks by the interface between non-Picis clinical systems (your “HIS” or “CIS”) and certain Picis applications, if that interface is not configured properly.

RECALLING FIRM/MANUFACTURER
Picis Inc., Wakefield, MA, by letter on April 8th 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
325 units

DISTRIBUTION
Nationwide, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom

About the author

Amy Sellers

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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