Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
FDA device recall Z-0857-2016 · posted 2016-02-23 · Terminated
Recall details
- Recalling firm
- Philips Electronics North America Corporation
- Reason for recall
- Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
- Action taken
- Philips Healthcare issued a Field Safety Notice on 11/25/15 to inform 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 software correction free of charge. On 1/28/16 the Philips issued an updated letter to users.Philips has initiated a correction to address this issue. A software correction will be provided to customers with impacted devices at no charge. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice: Arrhythmia alarms are not affected. ST alarms, ST values and measurements are also not affected and could be used to assist with the decision to obtain a diagnostic ECG. The ECG waves at the bedside are not affected. Printing ECG waves from the bedside is an alternative to printing from the PIIC iX. If you need any further information or support concerning this issue, contact your local Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 with questions or concerns about this Device Correction.
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 5569 units
- Distribution
- Worldwide Distribution-US (nationwide) and the countries of Algeria Australia Austria Belgium Bulgaria Canada Denmark Estonia Finland France Germany Hong Kong Hungary Iceland India Indonesia Iraq Irel
- Date initiated
- 2015-11-25
- Date posted
- 2016-02-23
- Date terminated
- 2017-09-06
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0 (K102495) | Philips Medical Systems | 2010-09-30 |