Data Foundry

Medical device recalls 2016

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 numberZ-2681-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPhilips Electronics North America Corporation, Andover, MA, United States
Recall initiated2016-08-12
Classified2016-08-29
Reported by FDA2016-09-07
Terminated2020-07-15
DistributedAK, 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 USBR, CA, DE, IQ, JP, KR, KW, MX, PT, QA
Quantity388
Serial numbers16620838, 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 numbers732027, 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

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2681-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

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.