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FDA device recall Z-0013-2014 · posted 2013-10-17 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with protocols using a Rotation Time of 0.4 seconds.

Action taken

Philips sent an "Urgent - Medical Device Correction" letter dated August 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Field Safety Notice is intended to inform you about: " what the problem is and under what circumstances it can occur " the actions that should be taken by the customer / user in order to prevent risks for patients or users " the actions planned by Philips to correct the problem If you need any further information or Support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1 -800-722-9377, Option 5: Enter Site ID or follow the prompts). This notice has been reported to the appropriate Regulatory Agency. Philips apologizes for any inconveniences caused by this problem

Root cause

Software design

Status

Terminated

Product code

JAK

Quantity affected

258

Distribution

Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AR, AZ, CA, CO, CT, GA, HI, IL, IN, KS, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR,TN, TX, UT, VA, VT and WV.,

Date initiated

2013-08-30

Date posted

2013-10-17

Date terminated

2014-05-14

Location

Cleveland, OH

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