Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F.01.00 or F.01.01 and with all

FDA device recall Z-1609-2011 · posted 2011-03-08 · Terminated

Recall details

Recalling firm

Philips Healthcare Inc.

Reason for recall

Software: EtCO2 and Ventilation Rate values may be labeled incorrectly.

Action taken

Philips Healthcare representatives issued an Urgent Medical Device letter on 2/7/11. Customers are asked to follow the Action to be taken by Customer/User section of the Urgent Medical Device Correction Notification. In this section, customers are given the following instructions: Philips software (SW) version F.01.03 (for M3535A and M3536A) and R.01.00 (for M3536A, English only) corrects this problem. If you have affected product a Philips Service Engineer will contact you to install software version F.01.03 or R.01.00. Until your software is updated your HeartStart MRx monitor/defibrillator can remain in service. If you are using the device in one of the use modes listed under problem description, make sure that operators are aware that even though the EtCO2 and ventilation rate values can display interchangeably (unexpectedly or randomly switch) under either the ventilation rate label or the EtCO2 label, the values themselves can be identified by their color (for example if the ventilation rate label is white, the ventilation value is displayed as white). Customers are to contact their local Philips representative at 1-800-722-9377, if they need further information or support regarding this issue.

Root cause

Software design

Status

Terminated

Product code

MKJ

Quantity affected

2382 units

Distribution

Worldwide -- USA, Canada, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FRANCE, GERMANY, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, KENYA, LATV

Date initiated

2011-02-07

Date posted

2011-03-08

Date terminated

2017-03-16

Location

Andover, MA

Related 510(k) clearances