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LATITUDE Paceart Integration Software, version 1.00 Model… recallZ-0037-2012 · Boston Scientific CRM Corp · initiated Aug 12, 2011

Terminated All recalls posted in October 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific CRM Corp or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Boston Scientific has determined that under certain conditions, LATITUDE Paceart Integration (LPI) software may not properly transfer data resulting in the incorrect summary of programmed parameter values in the ICD Summary tab display and Current Programming Tachy summary section of the Paceart report.

FDA root cause category: Software design

What the company is doing

Consignees were sent on 8/12/11 a Boston Scientific letter dated August 2011. The letter was addressed to "Dear Doctor". The letter described the product and problem. It also gave Background Information, Description of Potential Data Translation Error, and Additional Information and Action information. A letter, including an HRS form, was also sent to all US LATITUDE Clinics that have active LPI software to notify them of the need to install the corrected LPI Software.

Recall details

Recall number
Z-0037-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 12, 2011
Posted by the FDA
Oct 12, 2011
Recalling firm
Boston Scientific CRM Corp
Quantity
398
Product code
LWS
FDA submissions
P910077
Distribution
Nationwide Distribution -- AL, AK, AZ, AR, CA, CO, CT DE, DC, FL, GA, IL,IN, IA, KS, KY, LA,ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OJ, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA,WV, WI, and WY.

Product description

LATITUDE Paceart Integration Software, version 1.00 Model 6472. LATITUDE Paceart Integration is software and therefore does not have any serial numbers. However, the software version affected is version 1.00 and is distributed on USB pen drives. These pen drives are lot number controlled and denoted as Model 6493. When used in conjunction with the LATITUDE EMR Integration software transfers data files from the Boston Scientific LATITUDE Patient Management system to a clinic's Paceart system.

Code information (models, lots, serial numbers)

software verson 1.00

Other devices under the same FDA submission

34 devices cleared under P910077 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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