ViSi Mobile Chest Sensor
Medical device recall Z-1818-2013. Published in FDA’s Enforcement Report on Aug 7, 2013.
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 Aug 7, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 2 states named in where it went
- 75 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?
Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
75 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial No. ACBE20120900183 ACBE20120900189 ACBE20120900205 ACBE20120900206 ACBE20121000217 ACBE20121000224 ACBE20121000225 ACBE20121000226 ACBE20121000231 ACBE20121000232 ACBE20121000236 ACBE20121000240 ACBE20121000245 ACBE20121000250…
Every code shown here, 1,210 characters
Serial No. ACBE20120900183 ACBE20120900189 ACBE20120900205 ACBE20120900206 ACBE20121000217 ACBE20121000224 ACBE20121000225 ACBE20121000226 ACBE20121000231 ACBE20121000232 ACBE20121000236 ACBE20121000240 ACBE20121000245 ACBE20121000250 ACBE20121000252 ACBE20121000259 ACBE20121000260 ACBE20121000261 ACBE20121000262 ACBE20121000271 ACBE20121100292 ACBE20121100296 ACBE20121100300 ACBE20130200445 ACBE20120900211 ACBE20121000222 ACBE20121000237 ACBE20121000246 ACBE20121000263 ACBE20121100277 ACBE20121100280 ACBE20121100283 ACBE20121100287 ACBE20121100291 ACBE20121100356 ACBE20121100360 ACBE20121100364 ACBE20130100394 ACBE20130100395 ACBE20130100397 ACBE20130100398 ACBE20130100399 ACBE20130100401 ACBE20130100402 ACBE20130100404 ACBE20130100405 ACBE20130100410 ACBE20130100411 ACBE20130100412 ACBE20130100415 ACBE20130100417 ACBE20121000218 ACBE20121000227 ACBE20121000270 ACBE20121100282 ACBE20121100286 ACBE20121100288 ACBE20121100301 ACBE20121100350 ACBE20121100352 ACBE20121100355 ACBE20130100369 ACBE20130100370 ACBE20130100374 ACBE20130100375 ACBE20130100376 ACBE20130100378 ACBE20130100379 ACBE20130100380 ACBE20130100384 ACBE20130100385 ACBE20130100388 ACBE20130100390 ACBE20130100392 ACBE20130100393
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 distribution including CA and UT.
The states and territories these words name
- California
- Utah
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 May 23, 2013.
- FDA classified it on Jul 29, 2013.
- FDA’s Enforcement Report published it on Aug 7, 2013.
- FDA terminated it on Sep 9, 2013.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Sotera Wireless, Inc., of San Diego, 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.”
- 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.