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Terminated

Philips Healthcare System X-ray Tomography Computed :

FDA Recall Z-0375-2017 · Posted None

Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeJAK
Date Initiated2016-03-15
Date Terminated2020-09-09
Product Quantity1363

Reason for Recall

It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.

Firm Action

Philips planned action: 1. Philips issued a customer notification letter on October 13, 2016. The letter includes a statement that the corrections will be made free of charge. 2. Philips will initiate a field corrective action to address the issue. 3. Philips will contact the customer and schedule an inspection to determine if the unit requires repair. 4. If repair is required, the couch horizontal linkage assembly will be replaced. For further questions please call (978) 659-3000.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

USA(nationwide) Distribution to the states of : AZ, NY, GA, UT, TN, TX, AR, NV, Il, FL, MS, LA, MD, MO, MA, OK, KY, WY, SC, ND, NE, DE, MI, WA, CT, RI, KS, OR, IN, PA, CA, NJ, NC, MN, AL and IA.

Official Source

View FDA Recall →

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

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