Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1065-2010

Hill-Rom TotalCare Bed System, Hill-Rom, Batesville, IN; Model P1900 and P1840. The product is used as an AC...

Hill-Rom Inc. / initiated 2010-01-01 / Terminated / root cause: manufacturing process

Hill-Rom, Inc. began a recall of Hill-Rom TotalCare Bed System, Hill-Rom, Batesville, IN; Model P1900 and P1840. The product is used as an AC powered adjustable hospital bed on . The reason FDA records is "The controls for nurse call, bed movement and entertainment functions on the intermediate rail may fail to function". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1065-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
Product
Hill-Rom TotalCare Bed System, Hill-Rom, Batesville, IN; Model P1900 and P1840. The product is used as an AC powered adjustable hospital bed.
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall
The controls for nurse call, bed movement and entertainment functions on the intermediate rail may fail to function.
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
Action
The firm sent a letter to each consignee dated January 4, 2010 advising them that a firm representative will visit the facility to make corrections. Hospitals were requested to take all of the affected beds out of service, if possible, until they are corrected, or to inspect and remove those with a problem out of service until they are corrected if all cannot be removed from service. If you have any questions concerning the recall, please contact Hill-Rom Technical Support at 1-800-445-3720 (U.S.).
Quantity in commerce
185
Distribution
Worldwide Distribution -- United States, Australia, Canada, France, Germany, Mexico, United Arab Emirates and United Kingdom.
Product codes and lots
Serial numbers K285AM5539 through K310AM5864. (Serial numbers K310AM5857 , K296AM5635 , K296AM5629 , K295AM5623 , K306AM5779 , K306AM5777 , K303AM5747 , K303AM5741 , K300AM5677 , K300AM5675 , K299AM5654 , K299AM5651 , K302AM5718 , K301AM5715 , K301AM5712 , K301AM5710 , K301AM5709 , K301AM5707 , K301AM5705 , K301AM5704 , K301AM5702 , K301AM5700 , K301AM5696 , K301AM5695 , K300AM5693 , K300AM5690 , K300AM5686 , K300AM5682 , K299AM5660 , K299AM5653 , K296AM5647 , K296AM5643 , K299AM5656 , K299AM5652 , K302AM5725 , K302AM5723 , K302AM5719 , K301AM5714 , K301AM5698 , K300AM5688 , K299AM5663 , K299AM5658 , K302AM5735 , K302AM5733 , K302AM5731 , K302AM5729 , K302AM5726 , K302AM5724 , K302AM5722 , K302AM5720 , K302AM5716 , K301AM5713 , K301AM5708 , K301AM5706 , K300AM5691 , K294AM5594 , K303AM5761 , K303AM5748 , K303AM5739 , K303AM5760 , K303AM5759 , K303AM5758 , K303AM5757 , K303AM5756 , K303AM5755 , K303AM5754 , K303AM5753 , K303AM5752 , K303AM5751 , K303AM5750 , K303AM5749 , K303AM5738 , K296AM5648 , K296AM5645 , K296AM5642 , K306AM5780 , K306AM5776 , K303AM5740 , K302AM5737 , K302AM5734 , K302AM5732 , K302AM5730 , K302AM5728 , K302AM5721 , K300AM5678 , K300AM5676 , K300AM5674 , K299AM5669 , K299AM5666 , K299AM5665 , K299AM5662 , K296AM5644 , K296AM5641 , K296AM5639 , K296AM5637 , K296AM5631 , K295AM5619 , K308AM5812 , K307AM5797 , K306AM5775 , K306AM5772 , K306AM5771 , K306AM5770 , K306AM5769 , K306AM5768 , K306AM5767 , K306AM5766 , K306AM5765 , K306AM5764 , K306AM5763 , K299AM5671 , K299AM5668 , K299AM5667 , K299AM5664 , K299AM5661 , K299AM5659 , K299AM5655 , K303AM5746 , K303AM5745 , K303AM5744 , K303AM5742 , K294AM5599 , K294AM5584 , K300AM5687 , K300AM5692 , K300AM5689 , K300AM5685 , K300AM5683 , K300AM5673 , K299AM5670 , K302AM5727 , K294AM5595 , K294AM5593 , K294AM5591 , K294AM5590 , K294AM5587 , K299AM5650 , K296AM5649 , K296AM5640 , K296AM5638 , K296AM5636 , K296AM5634 , K296AM5630 , K296AM5628 , K295AM5625 , K295AM5624 , K295AM5622 , K295AM5621 , K295AM5620 , K295AM5618 , K295AM5616 , K295AM5614 , K295AM5612 , K295AM5611 , K295AM5609 , K295AM5607 , K294AM5605 , K294AM5604 , K294AM5600 , K294AM5596 , K294AM5586 , K294AM5585 , K294AM5583 , K294AM5582 , K294AM5579 , K294AM5578 , K299AM5589 , K294AM5601 , K294AM5598 , K294AM5603 , K294AM5592 , K302AM5717 , K301AM5711 , K301AM5699 , K301AM5697 , K300AM5684 , K300AM5672 , K301AM5703 , K301AM5701 , K296AM5646 , K294AM5588 , K294AM5581 , K294AM5580 , K296AM5633 and K295AM5627).