superDimension, Inc: superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

Recall number

Z-2001-2012

Recalling firm

superDimension, Inc

Product

superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

Status

Terminated

Initiated

2012-06-18

Posted

2012-07-12

Terminated

2013-02-28

Reason

superDimension, Inc., is conducting a recall of certain superDimension Systems operating Software Version 4.0 - 4.9. The affected systems are sold under the product code AAS00016-xx. The products being recalled have been found to malfunction when connected to the superDimension Locatable Guide (LG). Specifically, the Systems using Software Version 4.0-4.9 will not recognize the Locatable Guide

Root cause

Device Design

Action

superDimension sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 15, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter advised customers to discontinue use of the system and requested consignees to complete and return the acknowledgement receipt form via fax to 763-210-4098. Contact the firm at 763-210-4057 for questions regarding this recall.

Quantity

99

Distribution

Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, and Wisconsin and the countries of Canada, Australia, Austria, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, South Africa, Spain, Switzerland, Turkey, and United Kingdom.

Lot, serial or model codes

S030097 S0030044 S030065 S030092 S030579 S420011 S420102 I4202008 S0030045 S030066 S030092 S030586 S420012 S420105 I4202012 S00312 S030067 S030094 S030587 S420013 S420107 S0030011 S030043 S030069 S030096 S030588 S420015 S420108 S0030013 S030046 S030070 S030098 S030604 S420019 S420109 S0030014 S030049 S030072 S030099 S030605 S420020 S420110 S0030015 S030052 S030075 S030102 S030608 S420021 S420112 S0030017 S030054 S030076 S030105 S030609 S420026 S420114 S0030021 S030056 S030077 S030449 S300049 S420036 S420125 S0030022 S030057 S030080 S030477 S300082 S420037 S830001 S0030023 S030058 S030081 S030492 S310078 S420077  S0030024 S030059 S030083 S030541 S310100 S420079  S0030025 S030060 S030085 S030546 S420006 S420080  S0030026 S030061 S030087 S030547 S420008 S420092  S0030042 S030064 S030089 S030573 S420009 S420100

510(k) numbers

K052260

PMA numbers

not on file

Product code

OGK

Firm FEI

3004962788

Firm city

Minneapolis

Firm state

MN

Firm country

not on file

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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