—#107923

Product

IntelliSpace Portal, M/N 881001, IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin- client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060937
Affected lot / code info: M/N 881001, Serial Numbers: 30001, 30003, 30004, 30007, 30008, 30016, 30018, 30019, 35006, 79932, 79933, 79935, 79936, 79939, 79940, 80071, 80425, 80891, 80910, 80914, 80979, 80980, 80994, 81004, 81008, 81015, 81026-81028, 81031, 81035, 81063, 81065, 81079, 81081, 81085, 81089, 81119, 81127, 81129, 81130, 81132, 81133, 81147, 81150, 81157, 81161, 81163-81165, 81169, 81172, 82004, 82006-82009, 82011, 82015-82018, 82020, 82021, 82023-82030, 85006-85011, 85025-, 5027, 85029, 85041-85043, 85046, 85049, 85053, 85067 & 85068.

Why it was recalled

A number of non-conformances were logged for IntelliSpace Portal running software version 4.0 during in-house random verification testing. When loading a study to Review, after failing to load it through Add to Running Application the Analysis application is not being closed and different (1st loaded study) patient appears in analysis (CCA).

Root cause (FDA determination)

Software design

Action the firm took

Philips Healthcare sent an Urgent Medical Device Correction letter dated February 23, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the communication. Customers were asked to retain a copy with the equipment instruction for use. For any further information or support customers should contact their local Philips representative or local Philips Healthcare office. Customers in North America and Canada should contact the Customer Care Solutions Center at 1-800-722-9377, option 5. For questions regarding this recall call 440-483-7000.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Road, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: Worldwide Distribution - USA including AL, AR, FL, GA, IO, IN, MI, NJ, NY, OH, OK, OR, PA, SC, TN, TX & WA and the countries of Australia, Canada, China, Czech Republic, France, Germany, India, Indonesia, Israel, Italy, Poland, Spain, Sweden, Switzerland & United Kingdom

Timeline

Recall initiated: 2012-02-22
Posted by FDA: 2012-03-30
Terminated: 2013-02-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107923. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.