PCR Compano Basic Reader using 100-127V as mains voltage — Class II medical device recall Z-2681-2016
Terminated recall by Philips Electronics North America Corporation, reported 2016-09-07, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. A defect component of the Compano reader power supply can cause the power supply to burn and some smoke to lea
| Recall number | Z-2681-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2016-08-12 |
| Classified | 2016-08-29 |
| Reported by FDA | 2016-09-07 |
| Terminated | 2020-07-15 |
| Distributed | 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, WY |
| Countries outside the US | BR, CA, DE, IQ, JP, KR, KW, MX, PT, QA |
| Quantity | 388 |
| Serial numbers | 16620838, 16620840, 16620843, 16620844, 16620845, 16720992, 16721001, 16721003, 16721005, 16921351, 17121932, 26422953, 26523285, 26523286, 26523287, 26523292, 26723780, 26723781, 2672378226422949, 26824118, 26824120, 26924172, 26924179, 27024418, 27024470 and 358 more |
| Model numbers | 732027, 732028, 732040 |
Product
PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography).
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.