Recall Z-2681-2016 ยท LLZ System, Image Processing, Radiological
Philips Electronics North America Corporation
PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography).
| Date | Aug 12, 2016 |
| Status | Terminated |
| Reason | A defect component of the Compano reader power supply can cause the power supply to burn and some smoke to leave the housing. |
| Root cause | Component design/selection |
| 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). |
| Quantity | 388 |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964124 | PHILIPS COMPUTED RADIOGRAPHY Philips Medical Systems, Inc., Dec 18, 1996 |