AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE

FDA device recall Z-0899-2017 · posted 2016-12-22 · Terminated

Recall details

Recalling firm

Radiometer America Inc

Reason for recall

Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.

Action taken

Radiomet4er sent a letter dated November 30, 2016, to all affected customers via email with a request for customers to complete a return form. Customers/Users were advised to not use the "more" button to expand patient results when viewing them in the AQURE patient view. Customers/Users Radiometer Representative will contact them to schedule a visit of a remote session. During the visit or remote session the representative will run a script on the AQURE system, which serve to remove the misalighnment possibility. It is noted in the letter to customers that expanding the results by using the More button will not affect the stored results. If customers are not the end-user of the affected product ensure that the notification letter is distributed to the final end-user. If any questions regarding the notification letter contact Radiometer America Technical Support at 1-800-736-0600 opt.1. For questions regarding this recall call 440-871-8900.

Root cause

Software design

Status

Terminated

Product code

CHL

Quantity affected

7 total (2 in US)

Distribution

Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates.

Date initiated

2016-11-23

Date posted

2016-12-22

Date terminated

2017-02-07

Location

Brea, CA

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