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.

Terminated

Monitor Ceiling Suspension for Fluoroscopic and Angiographic X-Ray Systems.

FDA Recall Z-0097-04 · Posted 2004-07-20

Recalling FirmPhilips Medical Systems Sales & Service Region No. America
Recall StatusTerminated
Product CodeIZI
Date Initiated2003-10-10
Date Terminated2006-02-13
Product Quantity570 units

Reason for Recall

The thumbscrew hinge pin on the monitor support arm could become loose allowing the monitor to fall.

Firm Action

The firm issued a letter dated October 10, 2003 to all affected customers. The suspension will be upgraded by field service personnel starting October 24, 2003.

Root Cause

Other

Distribution Pattern

The firm distributes to hospitals and medical centers.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K923813PHILIPS INTEGRIS V3000 ROTATIONAL ANGIO FUNCTIONPhilips Medical Systems, Inc. · 1992-10-16K912470PHILIPS DIAGNOST 96Philips Medical Systems, Inc. · 1991-08-07

Official Source

View FDA Recall →

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

↑