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Terminated

GE Healthcare Transport Pro Monitor with the CARESCAPE" Patient Data Module.

FDA Recall Z-0363-2011 · Posted 2010-11-15

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeMHX
Date Initiated2010-10-05
Date Terminated2012-05-17
Product Quantity3256

Reason for Recall

Transport Pro Monitor stops communication with the CARESCAPE Patient Data Module (PDM) after 414 days of continuous run time. This time will equate to different amounts of real time depending on how much the units is actually in service per day. Transport Pro contains an internal timer that is used to control the software and remind users to perform preventive maintenance. When this internal timer

Firm Action

GE Healthcare issued an "Urgent Medical Device Correction" letter dated September 17, 2010 to consignees. The letter was addressed to Hospital Administrator, Head of Biomedical Engineering and Nursing Manager. The letter described the product, Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Service representatives will updates all of the affected Transport Pros with PDM that were distributed. Customers may contact GE at 262-548-2731 about this correction.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution: Domestic in the states of AL, AZ, AR, CA,CT, CO, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, ME, MI, MN, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, PA, SC, TN, TX, VA, VT, WA, WI, and WY, and Internation in the countries of BRAZIL, BERMUDA, BELGIUM, AUSTRIA, AUSTRALIA, CANADA, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY GREECE, INDONESIA, IRELAND, ITALY, JAPAN, JORDAN, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MAURITIUS, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, REPUBLIC OF KOREA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD 7 TOBAGO, and the UNITED KINGDOM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071073SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULEGe Medical Systems Information Technologies · 2007-05-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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