Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facili
FDA device recall Z-0268-2018 · posted 2017-12-20 · Terminated
Recall details
- Recalling firm
- Philips Electronics North America Corporation
- Reason for recall
- 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.
- Action taken
- 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
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 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,
- Date initiated
- 2017-09-20
- Date posted
- 2017-12-20
- Date terminated
- 2020-04-17
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURESIGNS VS2+ -SURESIGNS VSI (K112652) | Philips Medical Systems | 2011-10-11 |