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

Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

FDA Recall Z-1510-2014 · Posted 2014-04-26

Recall StatusTerminated
Product CodeKPS
Date Initiated2014-03-10
Date Terminated2015-08-04
Product Quantity1,043 cameras

Reason for Recall

Slippage of the radius drive belt in the relative 180 degree orientation of the superior positioned detector head will allow the detector head to drift down and potentially come in direct contact with the patient.

Firm Action

On 03/10/2014, the firm sent Urgent - Medical Device Correction letters to their customers. The letter identified the affected product, the reason for recall, the hazard involved, and the actions that should be taken by customers. Customers are to cease use of the identified procedures until implementation of the Field Change Order. Additionally, customers should sign and return the attached Customer Response Form within 10 days of receipt, acknowledging that they have read and understood the Field Safety Notice and Addendum. The Field Safety Notice must be placed in customers' User Documentation. Customers are to contact their local Philips Healthcare representative or office, if they need further information or support.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution -- USA, and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Ireland, Italy, Korea, Lebanon, Malaysia, Netherlands, Norway, Pakistan, Portugal, Russia, Singapore, Spain, Sweden, Thailand, & United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

↑