Recall Z-0670-2008 ยท DPW Flowmeter, Blood, Cardiovascular
Parks Medical Electronics Inc
Parks Medical Ultrasonic Doppler Flow Detector, Model 811-B (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007
| Date | Jul 3, 2008 (initiated Nov 8, 2007) |
| Status | Terminated |
| Reason | Premature battery failure: Wrong acid flux used on circuit board which may lead to premature battery failure of ultrasonic non-directional doppler flowmeter. |
| Root cause | Process control |
| Action | 811-B: On 9/28/07 Parks Medical Electronics notified their related U.S. distributor, Parks Medical Electronics Sales, Inc., Las Vegas, NV by email instructing them to stop further shipments. On 10/1/07 firm followed up with phone call instructing all units be returned for rework. On 11/8/07 firm sent replacement units accompanied with a Warranty Exchange Letter to their other U.S. customers notifying them of affected units. Letters were customized for each customer with a fill-in-the-blank of the model and serial numbers. Letters and replacement units were sent UPS 2nd Day Air and informed |
| Quantity | 122 units distributed to: 9 hospitals, 5 distributors, 5 veterinary clinics/hospitals, 1 veterinarian college. U.S., Ca |
| Distribution | Worldwide Distribution - USA, Brazil, Australia, and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.