Welch Allyn Vital Signs Monitor 5300 Series 300 Part numbers 007-0098-00 through 007-0159-00

FDA device recall Z-1333-04 · posted 2004-08-10 · Terminated

Recall details

Recalling firm

Welch Allyn Protocol, Inc

Reason for recall

Potential speaker failure could result in absence of audible annunciation of pulse tones, patient alarms and equipment alerts.

Action taken

The firm contacted their customers and their distributors customers via letters dated June 8, 2004 through July 9, 2004. The letters instruct their customers to verify speaker functionality. If the customers do not hear two quick beeps or there is static then they have a faulty speaker. The letters instruct them to stop using the monitor and contact Welch Allyn to have the monitor repaired. If the monitor continues to emit two quick beeps their customers are to contact Welch Allyn to have the monitor repaired as soon as it is convenient. The customers are to verify the two beeps prior to each use. The letter dated June 8, 2004 went to only a couple of direct customers. The remaining letters dated June 14, 2004, June 23, 2004, June 30, 2004 and July 9, 2004 went to direct customers, distributors and distributors'' end user customers.

Root cause

Other

Status

Terminated

Product code

DQA

Quantity affected

1828 units

Distribution

Welch Allyn distributes product to hospitals, physicians and distributors nationwide and internationally.

Date initiated

2004-06-08

Date posted

2004-08-10

Date terminated

2006-06-21

Location

Beaverton, OR