PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography).
FDA Recall Z-2681-2016 · Posted None
Advertisement
Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-08-12
Date Terminated2020-07-15
Product Quantity388
Reason for Recall
A defect component of the Compano reader power supply can cause the power supply to burn and some smoke to leave the housing.
Firm Action
Philips will send a Field Safety Notice to all affected customers on August 12, 2016. The notice informs consignees of the issue and informs them that Philips will replace the power supply unit of the PCR Compano Basic reader system of all affected units free of charge (FCO73200037).
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, TX, VT, WA, WI, WV, and WY; and, the countries of Canada, Brazil, Germany, Iraq, Japan, Korea, Kuwait, Libya, Mexico, Portugal, and Qatar.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement