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FDA Medical Device Recalls (openFDA)

Skf USA Inc: Matrix MAX3 Actuator, Catalog Number: MAX30 A300545A2510V000, SKF USA, Inc. Norristown, PA 19403

Recall number
Z-0216-2008
Recalling firm
Skf USA Inc
Product
Matrix MAX3 Actuator, Catalog Number: MAX30 A300545A2510V000, SKF USA, Inc. Norristown, PA 19403
Status
Terminated
Initiated
2007-07-24
Posted
2007-11-16
Terminated
2013-04-26
Reason
Sudden failure of the actuator during lifting operation
Root cause
Labeling design
Action
On or about 7/24/07, the firm sent an Important Safety Information letter and instructions to all known OEMs who purchase and sell SKF actuators for use in patient lifts. The letter reiterated and emphasized the importance of proper handling and maintenance for the actuator. The firm enclosed with this correspondence a proposed letter that the OEMs were asked to send to their customers, including the safety instructions and a new warning label. The firm also is making available for OEMs, dealers and their customers new warning labels to place on all actuators in service. The root cause of the problem is still under investigation by the recalling firm and additional instruction may follow later
Quantity
1,298 units (Z-0215-0217-2008)
Distribution
Worldwide Distribution-USA and Canada
Lot, serial or model codes
Serial number 3337328
510(k) numbers
not on file
PMA numbers
not on file
Product code
not on file
Firm FEI
3003668692
Firm city
Norristown
Firm state
PA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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