Recall Z-0696-2017— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-0696-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-12

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2016-11-12, terminated 2019-06-18. It names one FDA 510(k) clearance: K160743. Product: Ingenuity Core 128 728323. Reason: Software error due to the filament on timer.

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2016-11-12
Terminated: 2019-06-18
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 128 728323

Reason for recall

Software error due to the filament on timer

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