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Terminated

NM/CT 870 DR Model # H3100AS

FDA Recall Z-2998-2020 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeKPS
Date Initiated2020-08-14
Date Terminated2021-05-06
Product Quantity31 units

Reason for Recall

Rotor bearing screws were found loose on detector.

Firm Action

GE Healthcare issued an Urgent Medical device correction notification on August 14, 2020. It states the following: 1. GE Healthcare will inspect and, if required, correct all affected products at no cost to you. 2. A GE Healthcare representative will contact you to arrange for the correction 3. Please complete the acknowledgement form and return it to GE Healthcare promptly upon receipt and no later than 30 days from receipt to [email protected] If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Root Cause

Use error

Distribution Pattern

USA : AR CT FL GA IL KS KY LA MA MD MI MN MO NE NJ NV NY OH OK RI SC TN TX VA VT WA WI OUS: ARGENTINA AUSTRIA BELGIUM BRAZIL Canada CHINA FRANCE GERMANY GREECE INDIA ISRAEL ITALY JAPAN Korea (Republic of) NETHERLANDS NORWAY PANAMA POLAND PORTUGAL Russia SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM VIETNAM

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093514DISCOVERY MODEL NM/CT 670Ge Medical Systems F.I. Haifa · 2009-12-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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