ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the…
Medical device recall Z-1927-2018. Published in FDA’s Enforcement Report on May 30, 2018.
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 30, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 667 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?
Getinge has received complaints concerning the X TEN Surgical Lights whose spring arms have broken, causing light heads to separate from the assembly. The issue relates to cracking of the spring arms at the weld seams that has the potential to develop into breaks with heavy use and aging of the equipment.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094
667, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Nos. ON000104 ON000104 ON000108 ON000108 ON000300 ON000302 ON002984 ON002986 ON002990 ON003002 ON003003 ON005382 ON005383 ON005432 ON005433 ON005434 ON005435 ON007749 ON007751 ON007762 ON007767 ON007769 ON007770 ON007771 ON007772…
Every code shown here, 1,992 characters
Serial Nos. ON000104 ON000104 ON000108 ON000108 ON000300 ON000302 ON002984 ON002986 ON002990 ON003002 ON003003 ON005382 ON005383 ON005432 ON005433 ON005434 ON005435 ON007749 ON007751 ON007762 ON007767 ON007769 ON007770 ON007771 ON007772 ON007773 ON007775 ON007776 ON007777 ON007778 ON009146 ON009147 ON009148 ON009149 ON009150 ON009151 ON009152 ON009153 ON009154 ON009155 ON009156 ON009157 ON009160 ON009162 ON009163 ON009164 ON009165 ON009166 ON009172 ON009173 ON009174 ON009178 ON009215 ON009216 ON009217 ON009218 ON009219 ON009234 ON009237 ON009239 ON009240 ON012141 ON012142 ON012143 ON012144 ON012146 ON012155 ON012156 ON012158 ON013719 ON013720 ON013721 ON013722 ON015435 ON015436 ON015437 ON015438 ON015439 ON015440 ON015441 ON015442 ON015459 ON015460 ON015461 ON015462 ON015463 ON015464 ON015465 ON015466 ON015467 ON015468 ON015469 ON015470 ON015471 ON015472 ON015473 ON015474 ON015481 ON015484 ON015486 ON015487 ON015488 ON015493 ON015497 ON015498 ON015500 ON015502 ON016035 ON016036 ON016037 ON016038 ON016039 ON016041 ON016042 ON016048 ON016049 ON016050 ON016051 ON016052 ON016053 ON016055 ON016056 ON016057 ON016058 ON016066 ON016068 ON016075 ON016076 ON016077 ON016078 ON016083 ON016084 ON016085 ON016086 ON016087 ON016088 ON016089 ON016090 ON017096 ON017097 ON017098 ON017099 ON017100 ON017101 ON017102 ON017103 ON017105 ON017106 ON017107 ON017108 ON017109 ON017110 ON017111 ON017128 ON017129 ON017130 ON017131 ON017133 ON017138 ON017139 ON017140 ON017141 ON017142 ON017143 ON017182 ON017183 ON017184 ON017185 ON017186 ON017187 ON017188 ON017189 ON017190 ON017191 ON017192 ON017193 ON017194 ON017195 ON017196 ON017197 ON017199 ON017200 ON017201 ON017202 ON017203 ON017204 ON017205 ON017206 ON017207 ON017208 ON017209 ON017215 ON017216 ON017218 ON017219 ON020504 ON020505 ON020506 ON020507 ON020511 ON020512 ON020513 ON020514 ON020515 ON022976 ON022977 ON022978 ON022979 ON022980 ON022981 ON022982 ON022983 ON022984 ON023033 ON023034 ON023035 ON023036 ON023038 ON026418 ON026419…
FDA’s list runs to 6,014 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.
U.S. and Gov. accts.
These words name no state.
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 Nov 16, 2017.
- FDA classified it on May 23, 2018.
- FDA’s Enforcement Report published it on May 30, 2018.
- FDA terminated it on Jul 21, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GETINGE US SALES LLC, of Wayne, NJ.
- 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 6,014 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
-
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.