15

Feb

1999

Solar 7000/8000 Patient Monitors Class I

0

Solar 7000 and Solar 8000 Patient Monitors with Version 5D Software, used to display physiological data from modules which monitor the patient for ECG, blood pressure, cardiac output, respiration, pulseoximetry, etc. Recall #Z-727/728-9.

REASON

A software deviation can affect the alarm default settings, which may result in incorrect or missed alarm notification.

CODE

Solar 7000/8000 Patient Monitors with 5D software, which had been updated from Version 5A, B or C
software, are affected. New units, which only had 5D software installed at the manufacturing plant, are not affected if they never had an earlier software version. There were, however, some units in stock which were updated at the manufacturer from Version 5C to Version 5D software when this became available on 12/18/98. Some of these new units were distributed. The affected new units were shipped between 12/18/98 and 2/10/99, but do not have consecutive serial numbers. These units, plus units which were updated with 5D software at users, are to be corrected in the field in the firm=s recall action.

MANUFACTURER

Marquette Electronics, Inc., Milwaukee, Wisconsin.

RECALLED BY

Manufacturer, by letters on February 5 and 15, 1999. Firm-initiated field correction ongoing.

DISTRIBUTION

Nationwide and international.

QUANTITY

607 new units affected by the problem and 97 Version 5D software update kits were distributed. It is unknown how many of the 97 software update kits have been installed on units which previously had
Version 5A, B, or C software.

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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