Model 3300 LATITUDE(TM) Programming System Product recall
Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and…
Why was Model 3300 LATITUDE(TM) Programming System Product recalled?
There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 001343 000488 000903 001404 000923 001352 001441 000203 000224 000255 000284 000434 000441 000445 000501 000515 000519 000521 000534 000536 000546 000553 000578 000588 000601 000602 000605 000606 000609 000610 000616 000617 000620 000628 000631 000633 000634 000636 000637 000638 000643 000644 000661 000664 000666 000667 000669 000671 000673 000677 000679 000682 000688 000690 000691 000700 000710 000717 000719 000720 000723 000726 000746 000757 000765 000924 001125 001556 001562 001564 001571 001574 001615 000598
- Product
- Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 74 units
- Distribution
- Worldwide distribution - US Nationwide in the State of FL, UT, and VA, and countries of Austria, Czech Republic, Germany, Greece, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom, Switzerland
- Recall date
- October 3, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)