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Terminated

Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

FDA Recall Z-0852-2021 · Posted None

Recalling FirmPhilips North America, LLC
Recall StatusTerminated
Product CodeLLZ
Date Initiated2020-11-19
Date Terminated2023-04-19
Product Quantity2714

Reason for Recall

A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.

Firm Action

On 11/23/2020, Philips issued Urgent Device Correction notices to customers via press release, letter, telefax, telephone, e-mail, visit, etc. Due to a software defect Philips is notifying all affected users of the JETStream Workspace Thyroid Analysis application recommending that customers calculate thyroid uptake utilizing the method provided in the notices and not using the Transfer Coefficient parameter.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, Mexico, Algeria, Argentina, Australia, Bahrain, Austria, Belgium, Brazil, China, Columbia, Cuba, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guatemala, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Kuwait, Latvia, Libya, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, United Kingdom, Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061029JETSTREAM WORKSPACEAdac Laboratories · 2006-05-01K042880JETSTREAM WORKSPACEAdac Laboratories · 2004-11-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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