Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

CombiDiagnost R90 1.1 (709031)

FDA Recall Z-1088-2024 · Posted 2024-02-14

Recalling FirmPHILIPS MEDICAL SYSTEMS
Recall StatusOpen, Classified
Product CodeJAA
Date Initiated2022-02-11
Product Quantity130 units

Reason for Recall

While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.

Firm Action

An Important Product Notice (2021-PD-DXR-034) dated February 15, 2022 was issued via Certified Mail. Philips Field Service Engineers will contact customers to schedule an onsite visit to install update software correcting the issue. Customers are asked to follow the provided instructions to ensure there are no pending images before an exam circulate the notice to all users and to complete and return the response form and circulate the notice to all users of the device for awareness. Contact Philips Customer Care Solutions Center 1-800-722-9377 with questions.

Root Cause

Software design

Distribution Pattern

US Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME, MI, MN, NC, NJ, NY, TX, VA, WA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K203087CombiDiagnost R90Philips Medical Systems Dmc GmbH · 2020-12-03

Official Source

View FDA Recall →

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

↑