Recall Z-0390-2018— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-0390-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-10

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2017-11-10, terminated 2020-11-05. It names one FDA 510(k) clearance: K160743. Product: Ingenuity Core, (Code 728321) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.. Reason: Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2017-11-10
Terminated: 2020-11-05
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K160743 — Philips Ingenuity CTPhilips Medical Systems (Cleveland), Inc.·cleared 2016-08-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Ingenuity Core, (Code 728321) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.

Reason for recall

Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.

Data sourced from openFDA. This site is unofficial and independent of the FDA.