FDA Device recall Z-0361-2019

FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular s…

FDA Device
Class II
terminated
Published 2018-11-07

On 2018-11-07 the FDA classified a Class II recall of FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular s… by Inpeco, citing the firm has identified customer sites where there are modules on which the safety pacemaker label is missing. The information regarding the label included in the Operations Manua….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0361-2019
Classification	Class II
Status	terminated
Initiated	2018-08-24
Published	2018-11-07
Last updated	2026-09-13 11:54 UTC
Company	Inpeco
Distribution	n/a

Product

FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre- Analytical and Post-Analytical processing,

Reason

The firm has identified customer sites where there are modules on which the safety pacemaker label is missing. The information regarding the label included in the Operations Manual has been updated to specify that: 1) the risk of a pacemaker malfunction applies to anyone with a pacemaker who may work on these modules; and 2) the minimum safety distance has been increased to 200 mm (7.87") from the transport mechanisms. Any person with a pacemaker must not get closer than this distance from the modules axes.

Identifiers

code_info	FlexLab: SHL.001 TSH.003 FLX.003 DIA 007 DIA 008 AML.001 SHD.001 SHD.002 SHD.003 FLX.006 FLX.005 FLX.008 FL… FlexLab: SHL.001 TSH.003 FLX.003 DIA 007 DIA 008 AML.001 SHD.001 SHD.002 SHD.003 FLX.006 FLX.005 FLX.008 FLX.011 FLX.009 FLX.010 FLX.012 FLX.014 FLX.015 FLX.017 FLX.018 FLX.016 FLX.019 FLX.020 FLX.021 FLX.022 FLX.023 FLX.025 FLX.027 FLX.026 FLX.029 FLX.032 FLX.028 FLX.033 FLX.034 FLX.030 FLX.031 FLX.036 FLX.035 FLX.041 FLX.040 FLX.038 FLX.037 FLX.045 FLX.044 FLX.046 FLX.043 FLX.047 FLX.057 FLX.039 FLX.048 FLX.051 FLX.055 FLX.053 FLX.052 FLX.054 FLX.060 FLX.059 FLX.063 FLX.058 FLX.049 FLX.056 FLX.050 FLX.042 FLX.062 FLX.061 FLX.064 FLX.067 FLX.068 FLX.065 FLX.069 FLX.066 FLX.072 FLX.070 FLX.071 FLX.073 FLX.075 FLX.078 FLX.079 FLX.074 FLX.081 FLX.076 FLX.077 FLX.080 FLX.082 FLX.084 FLX.088 FLX.083 FLX.086 FLX.089 FLX.087 FLX.092 FLX.091 FLX.085 FLX.090 FLX.093 FLX.095 FLX.096 FLX.094 FLX.099 FLX.097 FLX.101 FLX.048 FLX.103 FLX.102 FLX.098 FLX.0104 FLX.0105 FLX.0106 FLX.0108 FLX.0

code_info

FlexLab: SHL.001 TSH.003 FLX.003 DIA 007 DIA 008 AML.001 SHD.001 SHD.002 SHD.003 FLX.006 FLX.005 FLX.008 FL…

FlexLab: SHL.001 TSH.003 FLX.003 DIA 007 DIA 008 AML.001 SHD.001 SHD.002 SHD.003 FLX.006 FLX.005 FLX.008 FLX.011 FLX.009 FLX.010 FLX.012 FLX.014 FLX.015 FLX.017 FLX.018 FLX.016 FLX.019 FLX.020 FLX.021 FLX.022 FLX.023 FLX.025 FLX.027 FLX.026 FLX.029 FLX.032 FLX.028 FLX.033 FLX.034 FLX.030 FLX.031 FLX.036 FLX.035 FLX.041 FLX.040 FLX.038 FLX.037 FLX.045 FLX.044 FLX.046 FLX.043 FLX.047 FLX.057 FLX.039 FLX.048 FLX.051 FLX.055 FLX.053 FLX.052 FLX.054 FLX.060 FLX.059 FLX.063 FLX.058 FLX.049 FLX.056 FLX.050 FLX.042 FLX.062 FLX.061 FLX.064 FLX.067 FLX.068 FLX.065 FLX.069 FLX.066 FLX.072 FLX.070 FLX.071 FLX.073 FLX.075 FLX.078 FLX.079 FLX.074 FLX.081 FLX.076 FLX.077 FLX.080 FLX.082 FLX.084 FLX.088 FLX.083 FLX.086 FLX.089 FLX.087 FLX.092 FLX.091 FLX.085 FLX.090 FLX.093 FLX.095 FLX.096 FLX.094 FLX.099 FLX.097 FLX.101 FLX.048 FLX.103 FLX.102 FLX.098 FLX.0104 FLX.0105 FLX.0106 FLX.0108 FLX.0

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0361-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.