Z-0852-2021Class II

Emission Computed Tomography System Image Process System -

Name: Z-0852-2021 Emission Computed Tomography System Image Process System -
Creator: Philips North America, LLC
Published: 2020-11-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-11-19 / Terminated / root cause: design

FDA source

Philips North America, LLC began a recall of Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of... on 2020-11-19. FDA classified it as Class II and gives the reason as "A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0852-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-19
Posted: 2021-01-13
Terminated: 2023-04-19
Recalling firm: Philips North America LLC
Product: 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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 2714
Distribution: 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.
Product codes and lots: Model# 882310,882311,882313 All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0852-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0852-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-13

Product code LLZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)