Recall Z-2035-2019 ยท DQK Computer, Diagnostic, Programmable
Spacelabs Healthcare, Inc.
Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
| Date | Jan 28, 2019 |
| Status | Terminated |
| Reason | Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms. |
| Root cause | Software design |
| Action | The recalling firm began issuing customer letters on 1/28/2019 via priority service, return receipt requested, to all U.S. customers. The letter was translated, as necessary, and emailed on 2/4/2019 to the international subsidiaries and distributors. The firm identified 6 new customers (5 U.S. and 1 international) and the letter for the 5 new U.S. customers was issued 5/30/2019 via priority service, return receipt requested. The letter for the 1 new international customer was emailed on 5/28/2019. |
| Quantity | 295 customer sites have the affected software versions |
| Distribution | Distribution was nationwide. There was also government and military distribution. Foreign distribution was made to Argentina, Bahrain, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Costa Rica, Czech Republic, France, Hong Kong, India, Indonesia, Italy, Kuwait, Malaysia, Mexico, Netherland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110779 | SPACELABS SMART DISCLOSURE SYSTEM Spacelabs Healthcare, Apr 19, 2011 |