M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091,

FDA device recall Z-2528-2017 · posted 2017-06-13 · Terminated

Recall details

Recalling firm

Philips Electronics North America Corporation

Reason for recall

Potential for early component failure.

Action taken

Philips sent an Urgent Medical Device Correction letter dated December 17, 2010, to all affected consignees. Philips will replace defective system boards in Hewlett Packard model rp5700 PCs sold with IntelliVue Information Centers to correct the problem. Philips Healthcare representatives will inspect all affected units, and any unit identified to have a defective system board will have its system board replaced at no charge to the customer. Philips is asking the following of customers in the Action to be Taken by Customer/User section of the FSN: Observe your system for any of the symptoms described in the Problem Description section above. If symptoms are noted, please contact your local Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 # 3, # 1. Do not rely exclusively on the audible alarm system for patient monitoring. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. For questions regarding this recall call 978-659-3000.

Root cause

Component design/selection

Status

Terminated

Product code

MHX

Quantity affected

607 units

Distribution

Worldwide Distribution - US (Nationwide) OUS: CANADA ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BELGIUM BRAZIL CHILE CHINA COLOMBIA CZECH REPUBLIC FINLAND FRANCE GERMANY GREECE INDIA INDONESIA IRELAND ITALY

Date initiated

2010-12-17

Date posted

2017-06-13

Date terminated

2017-08-01

Location

Andover, MA

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