IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Po

FDA device recall Z-2237-2014 · posted 2014-08-14 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

The following software issues have been identified in the affected products. Problem 1: When reopening a bookmark generated from processing a MUGA (Multi-Gated Acquisition) scan within the NM Cardiac Application, the ejection fraction (EF) displayed should be the same as the ejection fraction (EF) originally displayed when the bookmark was first created. In some instances, the ejection fraction (

Action taken

Philips Healthcare issued an Urgent Medical Device Correction letter dated July 28, 2014, via certified mail to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Philips Key Market representative would distribute the FSN internationally. Additionally, a Field Service Engineer would contact each site to schedule a time to install the software update. Customers with questions were instructed to contact their local Philips representataive or local Philips Healthcare office. For North America and Canada customers were instructed to contact the Customer Care Solutions Center at 1-800-722-9377, option 1. For questions regarding this recall call 978-659-7703.

Root cause

Software design

Status

Terminated

Product code

JAK

Quantity affected

1099 Units

Distribution

Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VT, WA, WI, WV, WY,Washington D.C. an

Date initiated

2014-07-27

Date posted

2014-08-14

Date terminated

2016-02-02

Location

Cleveland, OH

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