ATOM Medical Corporation

Incubators

Dual Incu i Model 100 Urgent Field Safety Notice May 2012

Alert

Dual Incu i Model 100 Urgent Field Safety Notice-Canopy can move May 2012

3 Pages

Urgent: Field Safety Notice Dual Incu i, Model # 100 May 1, 2012 Dear Distributor, Atom Medical is initiating a voluntary recall of the Dual Incu i; model number 100... he recall results from a potential for the device’s canopy to move unintentionally when using as incubator mode or radiant warmer mode... hile there have been no adverse events reported for these failure modes, if the malfunction occurs when an infant is in the incubator, the device may not operate as the intentional functions... his recall should be carried out to the end user level... our assistance is appreciated and necessary to prevent possible patient injury... o comply with this recall:     Immediately identify all devices in your inventory and quarantine them until the rework is complete... lease identify any customers to whom you have further distributed the product... ontact your customers at once and arrange a time in which the field service technician can perform the rework... he parts needed to complete the rework will be sent from Atom Medical’s export department... omplete rework of all affected devices and document rework on the Recall Response Forms provided (page 2 and 3)... ee attached instructions for rework... eturn the Recall Response Forms to Atom Medical (kira‐utc@atomed... , t‐sugino@atomed... , or matsumoto@atom‐ami... )... ll forms should be completed and returned by January 31, 2013... Atom Medical is conducting this recall voluntarily and with the knowledge of the U... Food and Drug Administration, TGA, and the relevant Competent Authorities... lease complete and return the enclosed response form as soon as possible... f you have any questions, please contact Tomoichi Kira, Tsuyoshi Sugino, or Nobuyuki Matsumoto at the email addresses above or via fax +81‐3‐3812‐3199... est regards, Tomoichi Kira Manager, Quality Control Distributor FSCA/Recall Response Form Must be completed and returned by January 31, 2013 Please acknowledge and document required information for all applicable boxes below:  I have read and understand the recall instructions provided in the May 1, 2012 letter... ame: Distributor:  I have checked my stock and have followed the requirements outlined in this recall notice... evice Model Number  Device Serial Number Date Rework Performed Signature of Person who Completed Rework I have identified and notified any end users that have used this product... se the following page to document the notification to the end user and to document the rework of their devices... Please Email, Fax, or Mail Completed Response Form(s) to: Email: kira‐utc@atomed... , t‐sugino@atomed... , or matsumoto@atom‐ami... Fax: +81 3 3812‐3199 Address: Atom Medical Attn: Tsuyoshi Sugino 3‐18‐15 Hongo, Bunkyo‐ku, Tokyo 113‐0033, Japan
File Type: PDF
File Size: 141KB
File Name: dual_incu_i_model_100_urgent_field_safety_notice-ca.pdf
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