CLASS II Device recall · Reported 7 Aug 2013 · FDA Enforcement Report
ViSi Mobile Monitor recalled by Sotera Wireless
Sotera Wireless is recalling ViSi Mobile Monitor, distributed in California, Utah. The recall was initiated on 23 May 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1817-2013
- FDA event ID
- 65718
- Recalling firm
- Sotera Wireless, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 May 2013
- FDA classified
- 29 Jul 2013
- Reported
- 7 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 23 May 2013 | Recall initiated by company | |
| 29 Jul 2013 | Classified by FDA | +67 days |
| 7 Aug 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US distribution including CA and UT.
Questions about this recall
Why was it recalled?
Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.
Which lots are affected?
Serial No. AAAA20120800519 AAAA20120800520 AAAA20120800526 AAAA20120800527 AAAA20120800533 AAAA20120800537 AAAA20120800538 AAAA20120800539 AAAA20120900544 AAAA20120900548 AAAA20120900557 AAAA20120900562 AAAA20120900564 AAAA20120900577 AAAA20120900578 AAAA20120900580 AAAA20120900584 AAAA20120900587 AAAA20120900591 AAAA20130400890 AAAA20130400896 AAAA20130400902 AAAA20130400909 AAAA20120800501 AAAA20121200604 AAAA20121200606 AAAA20121200609 AAAA20121200610 AAAA20121200611 AAAA20121200615 AAAA20121200617 AAAA20121200618 AAAA20121200620 AAAA20121200621 AAAA20121200624 AAAA20121200626 AAAA20121200628 AAAA20121200629 AAAA20121200630 AAAA20121200632 AAAA20121200636 AAAA20121200639 AAAA20121200640 AAAA20121200645 AAAA20121200647 AAAA20130100680 AAAA20130100684 AAAA20130100688 AAAA20130100689 AAAA20130100691 AAAA20130100692 AAAA20130100693 AAAA20130100694 AAAA20130100698 AAAA20130100699 AAAA20130100700 AAAA20130100701 AAAA20130100703 AAAA20121200605 AAAA20121200612 AAAA20121200613 AAAA20121200622 AAAA20121200625 AAAA20121200627 AAAA20121200633 AAAA20121200642 AAAA20121200643 AAAA20121200646 AAAA20121200648 AAAA20121200649 AAAA20121200650 AAAA20121200651 AAAA20121200652 AAAA20121200653 AAAA20130100654 AAAA20130100655 AAAA20130100656 AAAA20130100657 AAAA20130100658 AAAA20130100660 AAAA20130100661 AAAA20130100662 AAAA20130100664 AAAA20130100665 AAAA20130100666 AAAA20130100669 AAAA20130100670 AAAA20130100671 AAAA20130100672 AAAA20130100678
Where was it sold?
US distribution including CA and UT.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 65718This product is part of a recall event; the main page for the event is ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI) recalled | Sotera Wireless | Device Malfunction | CA, UT |
More recalls from Sotera Wireless
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI) recalled | Sotera Wireless | Device Malfunction | CA, UT |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |