Ultraview Digital Telemetry Transmitter, Model 90478 The Spacelabs Medical Digital Telemetry system provides continuous
FDA device recall Z-1652-2008 · posted 2008-09-18 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Incorporated
- Reason for recall
- Telemetry Modules are failing to alarm for low heart rate and asystole.
- Action taken
- On 07/18/08 Spacelabs Healthcare issued a "URGENT-MEDICAL DEVICE CORRECTION" letter, dated July 16, 2008, to all customers who received the Spacelabs Medical Telemetry Receiver-Model 90478. The letter states circumstances in which the alarm fails, how to test each module for high rate alarm prior to patient use and a temporary work around if the alarm failure exists.` Letters have a receipt acknowledgement to ensure each customer receives the letter. Spacelabs Technical Support will personally install the new software, version V3.05.07EN, in all Spacelabs Medical Telemetry Receivers Model 90478. Technical Support will also be responsible for responding to customer technical questions and ensuring each customer is upgraded regarding this medical device recall. For assistance contact SpaceLabs Medical at 1-425-657-7200.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DSI
- Quantity affected
- 37,590
- Distribution
- Nationwide and Internationally
- Date initiated
- 2008-07-18
- Date posted
- 2008-09-18
- Date terminated
- 2011-03-21
- Location
- Issaquah, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING (K925510) | Spacelabs Medical, Inc. | 1994-10-27 |