# FDA recall Z-0852-2021

> **Philips North  America, LLC** · Class II · device recall initiated 2020-11-19.

## 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.

## Reason for recall

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

## 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.

## Key facts

- **Recall number:** Z-0852-2021
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-19
- **Report date:** 2021-01-20
- **Termination date:** 2023-04-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0852-2021

## Citation

> AI Analytics. FDA recall Z-0852-2021. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-0852-2021. Source: US FDA. Licensed CC0.

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