APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product
Medical device recall Z-2755-2019. Published in FDA’s Enforcement Report on Oct 2, 2019.
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 Oct 2, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 21 states named in where it went
- 159 devices 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?
The firm identified customer sites where modules which the safety pacemaker label is missing. Information regarding the label included in the Operations Manual has been updated to specify: 1) the risk of malfunction applies to anyone with a pacemaker who may work on these modules; 2) the minimum safety distance has increased to 200 mm (7.87”) from transport mechanisms. Any person with a pacemaker must not get closer than this distance from modules axes.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
159 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All Lot Numbers ABT018 ABT070 ABT107 ABT135 ABT019 ABT074 ABT108 ABT136 ABT023 ABT075 ABT109 ABT137 ABT024 ABT077 ABT110 ABT138 ABT026 ABT078 ABT111 ABT139 ABT027 ABT081 ABT112 ABT140 ABT028 ABT082 ABT113 ABT142 ABT034 ABT083 ABT114 ABT143…
Every code shown here, 715 characters
All Lot Numbers ABT018 ABT070 ABT107 ABT135 ABT019 ABT074 ABT108 ABT136 ABT023 ABT075 ABT109 ABT137 ABT024 ABT077 ABT110 ABT138 ABT026 ABT078 ABT111 ABT139 ABT027 ABT081 ABT112 ABT140 ABT028 ABT082 ABT113 ABT142 ABT034 ABT083 ABT114 ABT143 ABT036 ABT084 ABT116 ABT144 ABT037 ABT086 ABT117 ABT145 ABT041 ABT088 ABT118 ABT146 ABT042 ABT089 ABT119 ABT147 ABT047 ABT091 ABT120 ABT149 ABT049 ABT092 ABT121 ABT150 ABT050 ABT093 ABT122 ABT151 ABT051 ABT094 ABT123 ABT152 ABT054 ABT096 ABT124 ABT153 ABT058 ABT097 ABT125 ABT154 ABT059 ABT098 ABT126 ABT156 ABT062 ABT099 ABT127 ABT157 ABT063 ABT100 ABT128 ABT158 ABT065 ABT101 ABT129 ABT159 ABT066 ABT102 ABT130 ABT067 ABT104 ABT131 ABT068 ABT105 ABT132 ABT069 ABT106 ABT133
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.
US: TX, VA, AZ, NV, MA, LA, MN, PA, SC, NJ, NY, CA, IL, IN, WA, FL, TN, PA, KS, ND, NC, CT OUS: Argentina, Australia, Belgium, Canada, China, Denmark, France, Greece, Hong Kong, Ireland, Italy, New Zealand, Norway, Oman, Pakistan, Philippines, Portugal, Russia, Saudi Arabia, Singapore, Spain, Taiwan, Turkey, UAE, UK, Venezuela
The states and territories these words name
21 states and territories.
Every one of them
- Arizona
- California
- Connecticut
- Florida
- Illinois
- Indiana
- Kansas
- Louisiana
- Massachusetts
- Minnesota
- North Carolina
- North Dakota
- New Jersey
- Nevada
- New York
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Virginia
- Washington
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 Sep 7, 2018.
- FDA classified it on Sep 26, 2019.
- FDA’s Enforcement Report published it on Oct 2, 2019.
- FDA terminated it on Feb 2, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Abbott Laboratories, Inc, of Irving, TX.
- 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.”
- 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.