Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.

FDA device recall Z-0583-2025 · posted 2024-12-03 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

Reason for recall

Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.

Action taken

Philips notified consignees on about 11/16/2024, via certified mail. Consignees were instructed to identify any affected units on hand, identify if those units contain the affected software version, complete and return the response form, and circulate the Urgent Field Safety Notice Letter to all users of the device. To protect the user and patient from the issue of Plan Box not Updated, remain vigilant and confirm table position during procedures. Press any of the Emergency STOP buttons to stop unintended patient table motion and follow safety instructions in Section 6 of the IFU: Working with Specialized Exams. To avoid the issue of Wrong Patient ID with Anonymous patient, the operator should verify the patient information loaded into the patient data field is correct before scanning and rename the Anonymous record with the patient s name at the time of the scan.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JAK

Quantity affected

301 units

Distribution

Worldwide - US Nationwide distribution in the states of AR, AZ, CA, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Australia, Austria, Belgium, China, Czech Republ

Date initiated

2024-11-16

Date posted

2024-12-03

Location

Cambridge, MA

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