Z-1817-2012Class II

TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that...

Name: Z-1817-2012 TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that...
Creator: American Optisurgical Inc
Published: 2012-02-22
License: https://open.fda.gov/license/

Tenex Health / initiated 2012-02-22 / Terminated / root cause: manufacturing process

FDA source

American Optisurgical Inc began a recall of TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console... on 2012-02-22. FDA classified it as Class II and gives the reason as "Two reasons for recall. 1. Incorrect pressure relief valve installed inside console, leading to a remote chance of a risk to health. 2. Technical Specifications, under Irrigation, the Operating Pressure value is...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1817-2012
Classification: Class II
Status: Terminated
Initiated: 2012-02-22
Posted: 2013-08-08
Terminated: 2012-06-15
Recalling firm: Tenex Health
Product: TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
Product code: LFL Instrument, Ultrasonic Surgical
Reason for recall: Two reasons for recall. 1. Incorrect pressure relief valve installed inside console, leading to a remote chance of a risk to health. 2. Technical Specifications, under Irrigation, the Operating Pressure value is incorrect.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, American Optisurgical Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter via email on February 23, 2012. An updated "URGENT: MEDICAL DEVICE RECALL" recall letter dated March 1, 2012 was sent via email on March 1, 2012 to its customer. This updated recall letter described the product, problem and actions to be taken. The letter notified the two reasons for recall: " An incorrect pressure relief valve has been installed inside the console. Should the regulator that controls pressure delivered to the inflation cuff fail, the pressure relief valve would not open until a pressure of 10psi was achieved, which may present a health risk". "The Operator's Manual included with the system, Rev. 1, has a typographical error. Specifically, in Section E. Technical Specifications, under Irrigation, the Operating Pressure value is incorrect". The updated recall included the above second reason for recall. The firm instructed the customer, for replacement of the pressure relief valve, and to return the revision 1 operator manual to the company's address using a pre-paid FedEx account. For questions call 949.580.1266 M-F, 7:00am to 5:00pm PST.
Quantity in commerce: 5units
Distribution: Nationwide distribution: MN only.
Product codes and lots: Product Codes: LFL, GEI, Serial #: 55400001, 55400002, 55400003. Part Order No: 554-0034-000 510(K) Mp.: K101561

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1817-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1817-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-15

Product code LFL

K101561UnclassifiedTx1 Tissue Removal SystemAmerican Optisurgical, Inc. / cleared 2010-08-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)