Ultraview Digital Telemetry Transmitter, Model 91341-09 The Spacelabs Medical Digital Telemetry system provides continuo

FDA device recall Z-2336-2008 · posted 2008-09-25 · Terminated

Recall details

Recalling firm

Spacelabs Healthcare, Incorporated

Reason for recall

During battery insertion there is potential for patient waveforms to move to an open receiver module or to an occupied receiver causing the intermittent inappropriate monitoring of both patients for several minutes.

Action taken

On 07/17/08 the firm issued a "URGENT - MEDICAL DEVICE CORRECTION" letter to their customers who received the Spacelabs Medical 1400 MHz Telemetry System - Model 91341-09. The letter states the circumstances in which the device malfunctions, instructions for staff to confirm at the time of the battery insertion that the data is appearing and to remove it from service if information is not appearing. Letters will be sent with a return receipt acknowledging each customer receives the Medical Device Correction letter. Spacelabs Technical Support will respond to all technical questions and personally upgrade all switches with resisters. Contact Spacelabs Medical at 1-800-522-7025 for assistance.

Root cause

Device Design

Status

Terminated

Product code

DSI

Quantity affected

2,055 transmitters

Distribution

Nationwide

Date initiated

2008-07-17

Date posted

2008-09-25

Date terminated

2011-02-16

Location

Issaquah, WA