Reported Aug 7, 2013 · Terminated
ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and…
Sotera Wireless, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sotera Wireless, Inc. · 9444 Waples St · San Diego, CA · 92121-2939
Is this the product you have?
- ViSi Mobile Monitor, Catalog No. 92-10010 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.
- Lot codes and dates
- Serial No.
90 of 90 codes
AAAA20120800519AAAA20120800520AAAA20120800526AAAA20120800527AAAA20120800533AAAA20120800537AAAA20120800538AAAA20120800539AAAA20120900544AAAA20120900548AAAA20120900557AAAA20120900562AAAA20120900564AAAA20120900577AAAA20120900578AAAA20120900580AAAA20120900584AAAA20120900587AAAA20120900591AAAA20130400890AAAA20130400896AAAA20130400902AAAA20130400909AAAA20120800501AAAA20121200604AAAA20121200606AAAA20121200609AAAA20121200610AAAA20121200611AAAA20121200615AAAA20121200617AAAA20121200618AAAA20121200620AAAA20121200621AAAA20121200624AAAA20121200626AAAA20121200628AAAA20121200629AAAA20121200630AAAA20121200632AAAA20121200636AAAA20121200639AAAA20121200640AAAA20121200645AAAA20121200647AAAA20130100680AAAA20130100684AAAA20130100688AAAA20130100689AAAA20130100691AAAA20130100692AAAA20130100693AAAA20130100694AAAA20130100698AAAA20130100699AAAA20130100700AAAA20130100701AAAA20130100703AAAA20121200605AAAA20121200612
- Serial No.
- Amount recalled
- 90 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Sotera Wireless, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.