GE Healthcare Solar 8000M System, a multiparameter physiological patient monitoring system intended for use on adult, pe
FDA device recall Z-0285-2009 · posted 2009-01-05 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- A software error has been discovered when using Combination Monitoring with Solar 8000M/i - PDM - Telemetry in combo mode. This error has only been noted with this particular configuration and mode of monitoring. It has not been observed in other monitoring applications. The software error will result in a reset of the Solar 8000M/i, causing a loss of monitoring for approximately 1-2 minutes a
- Action taken
- A GE Healthcare consignee letter was sent out 9/9/08. The letter dated August 26, 2008 was addressed to Healthcare Administrator/Risk Manger. The letter described the problem, product and provided recommendation.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DSI
- Quantity affected
- 2782
- Distribution
- Nationwide to: AL, AR, AZ, CA, FL, GA, IA, ID, IL, IN, MA, MI, MN, MO, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, and WI. OUS to include: Australia, Austria, Belgium, Brazil, Czech Republic, Denmark,
- Date initiated
- 2008-04-02
- Date posted
- 2009-01-05
- Date terminated
- 2012-05-17
- Location
- Wauwatose, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOLAR 8000M SYSTEM (K012467) | General Electric Medical Systems Information Techn | 2002-02-11 |