FDA Medical Device Recalls (openFDA)
Philips Healthcare Inc.: Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F.01.00 or F.01.01 and with all of the following hardware options EtCO2, IP and Temp. Used for the termination of ventricular tachycardia and ventricular fibrillation.
- Recall number
- Z-1609-2011
- Recalling firm
- Philips Healthcare Inc.
- Product
- Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F.01.00 or F.01.01 and with all of the following hardware options EtCO2, IP and Temp. Used for the termination of ventricular tachycardia and ventricular fibrillation.
- Status
- Terminated
- Initiated
- 2011-02-07
- Posted
- 2011-03-08
- Terminated
- 2017-03-16
- Reason
- Software: EtCO2 and Ventilation Rate values may be labeled incorrectly.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 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, LATVIA, MALAYSIA, MEXICO, NEW ZEALAND, NORWAY, PHILIPPINES, REUNION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.
- Lot, serial or model codes
- Software versions: F.01.00 or F.01.01
- 510(k) numbers
- ["K051134"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28