X-Ray Diagnostic Table
Medical device recall Z-1585-2016. Published in FDA’s Enforcement Report on May 4, 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 May 4, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 185 units 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?
Report of unintentional movement of table to reverse tilting.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky radiography
185 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial No. 0162A80301 0162A80302 0162A80303 0162A80401 0162A80403 0162A81001 0162A81002 0162A81003 0162A81101 0162A81102 0162A81103 0162A81104 0162A81105 0162A81106 0162A81301 0162A81302 0162A81303 0162A81304 0162A81501 0162A81502…
Every code shown here, 1,998 characters
Serial No. 0162A80301 0162A80302 0162A80303 0162A80401 0162A80403 0162A81001 0162A81002 0162A81003 0162A81101 0162A81102 0162A81103 0162A81104 0162A81105 0162A81106 0162A81301 0162A81302 0162A81303 0162A81304 0162A81501 0162A81502 0162A81503 0162A81504 0162A81505 0162A81601 0162A81602 0162A81603 0162A81701 0162A81702 0162A81703 0162A81704 0162A81705 0162A81801 0162A81803 0162A82101 0162A82102 0162A82202 0162A82203 0162A82301 0162A82302 0162A82501 0162A82502 0162A82601 0162A82602 0162A82701 0162A82702 0162A82703 0162A82801 0162A82802 0162A82902 0162A83001 0162A83002 0162A83101 0162A83201 0162A83202 0162A83301 0162A83302 0162A83401 0162A83501 0162A83502 0162A83601 0162A83602 0162A83702 0162A83801 0162A83901 0162A83902 0162A84001 0162A84101 0162A84102 0162A84201 0162A84202 0162A84203 0162A84301 0162A84302 0162A84401 0162A84402 0162A84501 0162A84502 0162A84601 0162A84602 0162A84701 0162A84702 0162A84802 0162A84901 0162A84902 0162A85001 0162A85002 0262A80101 0262A80102 0262A80201 0262A80202 0262A80301 0262A80302 0262A80501 0262A80502 0262A80701 0262A80702 0262A80801 0262A80802 0262A80901 0262A80902 0262A81001 0262A81101 0262A81202 0262A81301 0262A81302 0262A81401 0262A81402 0262A81501 0262A81502 0262A81601 0262A81701 0262A81702 0262A81801 0262A81802 0262A81902 0262A82002 0262A82101 0262A82102 0262A82201 0262A82202 0262A82402 0262A82502 0262A82601 0262A82701 0262A82702 0262A82901 0262A83201 0262A83202 0262A83401 0262A83501 0262A83502 0262A83602 0262A83701 0262A83702 0262A83801 0262A83802 0262A83902 0262A84101 0262A84102 0262A84201 0262A84302 0262A84401 0262A84501 0262A84502 3YAFC840A002 3YAFC840A003 3YAFC840A004 3YAFC8411001 3YAFC8413001 3YAFC8415001 3YAFC8415002 3YAFC8418001 3YAFC8418002 3YAFC841A001 3YAFC841A002 3YAFC841B001 3YAFC841B002 3YAFC841C001 3YAFC841C002 3YAFC8422001 3YAFC8422002 3YAFC8422003 3YAFC8425001 3YAFC8425002 3YAFC8427001 3YAFC8427002 3YAFC8427003 3YAFC8428001 3YAFC8428002 3YAFC8428003 3YAFC8428004 3YAFC842A001 3YAFC842A002 3YAFC842C001 3YAFC842C002…
FDA’s list runs to 2,125 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.
Nationwide Distribution
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 Mar 31, 2016.
- FDA classified it on Apr 28, 2016.
- FDA’s Enforcement Report published it on May 4, 2016.
- FDA terminated it on Jan 2, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Shimadzu Medical Systems, of Torrance, CA.
- 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 2,125 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.