Recall Z-1355-2023— Philips North America Llc

Name: FDA recall Z-1355-2023
Creator: U.S. Food and Drug Administration
Published: 2021-10-21

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2021-10-21. It names 2 FDA 510(k) clearances: K203087, K163210. Product: CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031. Reason: If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from the cabinet, or hear a popping sound coming from the cabinet..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2021-10-21
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K203087 — CombiDiagnost R90Philips Medical Systems Dmc GmbH·cleared 2020-12-03
K163210 — Philips CombiDiagnost R90Philips Medical Systems Dmc GmbH·cleared 2017-01-31

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

CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031

Reason for recall

If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from the cabinet, or hear a popping sound coming from the cabinet.

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