Recall Z-0268-2018 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips Electronics North America Corporation
Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.
| Date | Dec 20, 2017 (initiated Sep 20, 2017) |
| Status | Terminated |
| Reason | Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %DoM , instead of the specific date in the format of YYYY-MM. |
| Root cause | Error in labeling |
| Action | Philips sent each known affected customer a Field Safety Notice, dated September, 2017. The Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Philips will provide a corrected label free of charge |
| Quantity | 1079 |
| Distribution | Worldwide distribution. Australia, Austria, Bahrain, Belgium, Brazil, Denmark, France, French Polynesia, Germany, Hong Kong, India, Ireland, Israel, Italy, Kenya, Lebanon, Lesotho, Malaysia, Maldives, Morocco, Netherlands, Oman, Pakistan, Palestine, Poland, Saudi Arabia, South Africa, Spain, Sweden, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112652 | SURESIGNS VS2+ -SURESIGNS VSI Philips Medical Systems, Oct 11, 2011 |