Recall Z-1333-04 ยท DQA Oximeter
Welch Allyn Protocol, Inc
Welch Allyn Vital Signs Monitor 5300 Series 300 Part numbers 007-0098-00 through 007-0159-00
| Date | Aug 10, 2004 (initiated Jun 8, 2004) |
| Status | Terminated |
| Reason | Potential speaker failure could result in absence of audible annunciation of pulse tones, patient alarms and equipment alerts. |
| Root cause | Other |
| Action | 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 |
| Quantity | 1828 units |
| Distribution | Welch Allyn distributes product to hospitals, physicians and distributors nationwide and internationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.