Recall Z-1102-2012 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Mindray DS USA, Inc. d.b.a. Mindray North America
V Series Monitor Mindray DS USA, Inc. 800 MacArthur Boulevard. Mahwah, NJ 07430 The Indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements Heart Rate Pulse Oximetry (Sp02) ST Segment Analysis Arrhythmia Detection Non Invasive Blood Pressure (NIBP) Invasive Blood Pressure (IBP) Cardiac
| Date | Feb 24, 2012 (initiated Oct 14, 2011) |
| Status | Terminated |
| Reason | A system database corruption may occur that causes the V Series Monitor to reset. |
| Root cause | Process control |
| Action | The firm, Mindray, sent an "URGENT PRODUCT CORRECTIVE ACTION" letter dated October 14, 2011 on October 17, 2011 via certified mail, return receipt requested, signature required to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to contact their Mindray Service Representative at 1-800-288-2121, to arrange for software upgrade of the V Series Monitor(s) in their facility. If you have any questions, contact Manager, Regulatory Affairs and Clinical Affairs at 201-995-8407 or email: d.arpino@mindray.com. |
| Quantity | 542 units US ; 153 units International |
| Distribution | Worldwide distribution: USA (nationwide) including states of: AL, CA, CO, IN, MO, NE, PR, and SD; and countries of: Australia, Chile, Columbia, United Kingdom, and Venezula. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.