PCR Compano Basic Reader using 100-127V as mains voltage
Medical device recall Z-2681-2016. Published in FDA’s Enforcement Report on Sep 7, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 7, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 41 states named in where it went
- 388 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
A defect component of the Compano reader power supply can cause the power supply to burn and some smoke to leave the housing.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography).
388, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 2704471 2704473 16620843 16620844 16620845 16720992 16721001 17121932 26523285 26523287 26523292 26824120 26924172 26924179 27024418 27124646 27124650 27224878 27225020 36125096 36225366 36225367 36225370 36225371 36225372…
Every code shown here, 1,994 characters
Serial Numbers: 2704471 2704473 16620843 16620844 16620845 16720992 16721001 17121932 26523285 26523287 26523292 26824120 26924172 26924179 27024418 27124646 27124650 27224878 27225020 36125096 36225366 36225367 36225370 36225371 36225372 36225373 36225429 36225431 36225432 36225437 36225438 36325634 36325635 36325639 36325641 36325805 36325810 36325811 36325812 36325813 36325814 36325819 36325820 36425835 36425837 36425838 36425839 36425842 36526123 36526129 36526134 36526135 36526138 36526139 36526140 36526141 36526142 36526144 36526201 36526202 36526206 36526211 36526212 36526213 36626333 36726559 36726560 36726562 36826721 36826722 36826726 36826728 36926990 36926991 37127470 37127472 37127473 46127902 46127903 46127905 46127906 46127909 46127910 46127911 46127912 46127913 46127914 46127992 46127994 46127997 46128000 46128001 46128003 46128004 46128008 46128009 46128010 46128011 46228209 46228211 46228215 46228216 46228228 46228229 46328495 46328496 46328498 46328502 46328529 46328546 46328547 46328548 46358530 46428796 46428799 46428802 46428803 46428804 46428805 46428807 46428815 46428816 46529074 46529085 46629338 46629344 46629346 46629352 46629355 46629356 46629357 46629359 46629360 46629363 46729628 46729629 46729631 46729632 46729633 46729634 46729635 46729636 46729637 46729639 46729640 46729644 46729723 46729725 46729726 46829974 46829975 46829976 46829978 46829980 46829981 46829982 46829983 46829984 46829985 46829992 46829993 46829994 46829995 46829996 46930348 46930350 46930351 46930352 46930354 46930521 46930523 46930524 46930525 46930528 46930529 47030712 47030713 47030714 47030715 47030716 47030719 47030721 47030723 47030724 47030725 47030726 47131062 47131069 47131070 47131071 47131072 47131073 47131074 47131075 47231476 47231481 56232069 56232070 56232089 56232090 56232091 56332428 56332430 56332433 56332437 56332438 56332449 56332451 56332453 56432826 56432840 56432841 56432843 56432845 56432852 56533223 56533224 56533225 56533226 56533227…
FDA’s list runs to 3,480 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
41 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oregon
- Pennsylvania
- Texas
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 12, 2016.
- FDA classified it on Aug 29, 2016.
- FDA’s Enforcement Report published it on Sep 7, 2016.
- FDA terminated it on Jul 15, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Electronics North America Corporation, of Andover, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,480 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.