Company: TomoTherapy Inc. Date of Enforcement Report 9/3/2008 Class:ll PRODUCT TomoTherapy Hi-Art System with software versions 3.0 and 3.1 – Radiation Therapy System. The device is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy, Recall # Z-1615-2008 REASON In certain cases of HI-ART Systems operating...Read More

Company: Sunrise Medical, Inc Date of Enforcement Report 9/3/2008 Class:ll PRODUCT a) Quickie Rhythm Power Wheelchair with QC (non-expandable) electronics, Model number EIPW10, Recall # Z-1531-2008; b) Quickie Groove Power Wheelchair with QC (non-expandable) electronics, Model number EIPW13, Recall # Z-1532-2008 REASON Product experiences a longer than expected stopping distance, which may cause injury to...Read More

Company: Pride Mobility Products, Corp Date of Enforcement Report 9/3/2008 Class:ll PRODUCT Q-Logic Controller Software used on the following power wheelchairs: Q6000, Q6000XL, Q6000Z, R4000, Q600, Q600XL, Q610, Q1107, Q600E, and Dynamo 1107, Recall # Z-1776-2008 REASON Software – Watch dog timer feature was disabled RECALLING FIRM/MANUFACTURER Pride Mobility Products, Corp., Exeter, PA, by letter...Read More

Company: Philips Medical Systems Date of Enforcement Report 9/3/2008 Class:ll PRODUCT a) CareVue Chart Release C ,Versions C.00.00 through C.00.06 Product No. 862246. This device is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and other systems that are connected either directly or through networks. It...Read More

Company: Philips Medical Systems Date of Enforcement Report 9/3/2008 Class:ll PRODUCT General X-Ray System types with Digital Spot Imaging (DSI) software. Software version: rel 6, Recall # Z-2160-2008 REASON X-ray images may be stored in the wrong patient file or corrupted; images from two different patients may be combined in one patient’s folder or may...Read More

Company: Baxter Healthcare Corp Date of Enforcement Report 9/30/2008 Class:ll PRODUCT Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD, version 1.0.28 and Logix Compounder Manager (CM) Installation CD, version 3.1.8. The software is included in a number of Baxter’s pharmacy compounders. The software assists the pharmacist in management...Read More